A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome (NOR-CACTUS)

October 18, 2023 updated by: Hilde Berner Hammer, Diakonhjemmet Hospital

The NOR-CACTUS Trial - A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) causes numbness and pain in the hand and arm, and is an important cause of work absence and disability. The aim of the NOR-CACTUS Trial is to compare outcomes of a treatment strategy where the initial treatment is up to two ultrasound-guided corticosteroid injections, followed by scheduled clinical assessment of treatment effect, and subsequent surgery if needed, to a treatment strategy where surgery is the first-line treatment. Participants will be randomized to one of the treatment strategies, and followed up for two years after start of the study intervention. Outcomes will include patient-reported, clinical, functional and neurophysiological measures, and health-economic aspects. The hypothesis of the study is that there is no difference between the two treatment groups in the percentage of patients with a satisfactory symptom relief (treatment success) one year after the initial therapeutic intervention.

Study Overview

Detailed Description

CTS is the most common non-traumatic hand disorder, prevalent in approximately 4% of the adult population. The condition may have a substantial impact on an individual's quality of life, ability to accomplish activities of daily living, and to perform occupational duties. Associated healthcare costs represent a significant socioeconomic burden.

Currently, many patients with mild and moderate CTS treated surgically without a preceding trial of less invasive non-surgical therapies. An increase in the use of non-surgical first-line therapies (e.g. corticosteroid injection into the carpal tunnel), while reserving surgery for refractory cases, aim to optimize the trade-off between treatment risk and benefit, while also ensuring appropriate use of health resources. However, there is a lack of studies directly comparing the efficacy of corticosteroid injections to surgery, and the long-term safety of corticosteroid injections has not been investigated.

It is not well-known if patients who are initially treated with corticosteroid injections will eventually need to proceed to surgery, and therefore may have to endure the symptoms for a longer period of time, with potentially worse long-term outcomes, compared to patients who has surgery as first-line treatment. On the other hand, it is not beneficial if patients are unnecessarily exposed to the risks associated with surgery, if symptoms could have been satisfactory resolved with a non-surgical method.

The current study will assess if first-line treatment with up to two ultrasound-guided corticosteroid injections is non-inferior to surgery with regards to treatment success. A less invasive treatment approach might result in important benefits to the patient, e.g. less pain, reduced risk of complications, and faster return to work and activities. This might also be of importance to family members, as many CTS patients are at an age where they have care responsibilities. Non-surgical treatments might benefit society by decreasing work absence and reducing health expenditure, and allowing better access to surgical services for other patient groups. High quality documentation is needed to provide a base for future treatment guidelines. Evidence based clinical guidelines provide treatment decision support and help reduce national and regional differences in treatment practices, and ensure that all patients have equal access to evidence-based treatment.

In the NOR-CACTUS trial, adult individuals with idiopathic CTS of a mild-to-moderate degree will be randomized to receive either A) Primary open surgical carpal tunnel release, or B) Up to two ultrasound-guided corticosteroid (triamcinolone hexacetonide) injections in the carpal tunnel, and subsequent open surgical carpal tunnel release in case of unsatisfactory treatment result. Participants will be randomized to receive one of the treatment strategies, and followed for two years, with the primary endpoint being successful treatment result one year after start of the intervention.

The hypothesis of the study is that the percentage of patients with a satisfactory symptom relief (treatment success) one year after the initial therapeutic intervention in the injection treatment strategy arm is non-inferior to that of the surgery treatment arm. The primary outcome is based on the disease-specific patient-reported outcome Boston Carpal Tunnel Questionnaire (BCTQ) symptom severity scale (SSS). Further outcomes will include other patient-reported, clinical, functional and neurophysiological measures, and health-economic aspects.

Study Type

Interventional

Enrollment (Estimated)

258

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Oslo, Norway, 0319
        • Active, not recruiting
        • Department of Rheumatology, Diakonhjemmet Hospital
      • Sandvika, Norway
      • Sandvika, Norway
    • Norge
      • Oslo, Norge, Norway, 1450
        • Recruiting
        • Department of Surgery and Anesthesiology, Diakonhjemmet Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult (≥18 years of age)
  2. Patient history indicating CTS
  3. Neurophysiological examination performed within 6 months
  4. Diagnosis of CTS based on:

    1. Classic/probable or possible symptoms, and neurophysiological findings consistent with CTS

      Or, in case of normal neurophysiological findings:

    2. Classic/probable symptoms and positive physical exam findings and/or nighttime symptoms
  5. Mild to moderate symptoms (intermittent, interfering with everyday life, and/or disturb sleep)

Exclusion Criteria:

  1. Previous CTS surgery or corticosteroid injection in the carpal tunnel in the relevant hand
  2. Diagnosis of severe CTS, based on history and examination indicating severe CTS with constant symptoms including pain, loss of sensibility, dexterity or reduced temperature sensation, weakness of thumb abduction and opposition, or atrophy of thenar musculature. Disappearance of pain may indicate permanent sensory loss.
  3. History suggesting underlying causes of CTS e.g. inflammatory wrist arthritis and/or flexor tenosynovitis
  4. Previous significant trauma or fracture, deformity or tumor in the wrist or hand in the relevant hand
  5. Presence of conditions affecting a normal nerve function e.g. cervical disc herniation, polyneuropathy or previous nerve injury
  6. Major co-morbidities, such as severe malignancies, severe or uncontrolled infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV) and/or severe respiratory diseases, severe renal failure, active ulcus ventriculi, leukopenia and/or thrombocytopenia
  7. Severe psychiatric or mental disorders
  8. Local infection or wound in the affected hand/wrist
  9. Any other medical condition that according to the treating physician and/or local guidelines makes adherence to treatment protocol impossible
  10. Inadequate birth control1, pregnancy2, and/or breastfeeding (current at screening or planned within the duration of the study)
  11. Known hypersensitivity to Triamcinolone Hexacetonide (Lederspan) or any of the excipients (sorbitol, polysorbate or benzyl alcohol)
  12. Concomitant therapy with CYP3A-inhibitors or digitalis glycosides
  13. Patients vaccinated or immunized with live virus vaccines within 2 weeks of treatment
  14. Alcohol or other substance abuse
  15. Language barriers
  16. Other factors which make adherence to study protocol impossible

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Surgery treatment strategy
Primary open surgical carpal tunnel release. Treatment effect is monitored on scheduled follow-up visits. Re-operation may be performed if medically indicated (e.g. postoperative complication, or failure of the primary procedure)
Open surgical division of the flexor retinaculum of the palm/wrist to release pressure on the median nerve
Other Names:
  • Open surgical carpal tunnel release
Experimental: Injection treatment strategy
Primary treatment with ultrasound-guided corticosteroid injection. Treatment effect is monitored on scheduled follow-up visits. One additional injection may be administered, and subsequently surgical carpal tunnel release is performed in case of unsatisfactory treatment effect of the injection therapy. Treatment effect is graded on a 5-leve scale by subject from 1 (complete improvement) to 5 (severe worsening) of symptoms. Incomplete improvement (score 2 or higher) results in a second injection or secondary surgery.
Open surgical division of the flexor retinaculum of the palm/wrist to release pressure on the median nerve
Other Names:
  • Open surgical carpal tunnel release
Ultrasound-guided injection of 20 mg of triamcinolone hexacetonide (or -acetonide) into the carpal tunnel space close to the median nerve
Other Names:
  • Ultrasound-guided corticosteroid injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful treatment result after 12 months
Time Frame: 12 months

Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5 after 12 months

Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related symptom severity. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5. The primary outcome measure is achievement of BCTQ SSS ≤ 1.5, interpreted as a successful treatment result, 12 months after start of the study intervention.

12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful treatment result after 3 months
Time Frame: 3 months

Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5 after 3 months

Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related symptom severity. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5. The outcome measure is achievement of BCTQ SSS ≤ 1.5, interpreted as a successful treatment result, 3 months after start of the study intervention.

3 months
Successful treatment result after 6 months
Time Frame: 6 months

Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5 after 6 months

Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related symptom severity. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5. The outcome measure is achievement of BCTQ SSS ≤ 1.5, interpreted as a successful treatment result, 6 months after start of the study intervention.

6 months
Successful treatment result after 24 months
Time Frame: 24 months

Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5 after 24 months

Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related symptom severity. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5. The outcome measure is achievement of BCTQ SSS ≤ 1.5, interpreted as a successful treatment result, 24 months after start of the study intervention.

24 months
Boston Carpal Tunnel Questionnaire Symptom Severity Scale
Time Frame: 0-24 months

Boston Carpal Tunnel Questionnaire Symptom Severity Scale (range 1-5)

Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related symptom severity. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5, used as outcome measure.

0-24 months
Boston Carpal Tunnel Questionnaire Functional Status Scale
Time Frame: 0-24 months

Boston Carpal Tunnel Questionnaire Functional Status Scale (range 1-5)

Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related functional impairment. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5, used as outcome measure.

0-24 months
Nerve conduction studies: Motor median nerve distal latency
Time Frame: 0 and 12 months

Nerve conduction studies of motor median nerve distal latency (milliseconds)

Measurement points:

  • Distal: at the wrist, 8 cm proximal to the m. abductor pollicis brevis.
  • Proximal: at the cubital fossa
0 and 12 months
Nerve conduction studies: Motor median nerve proximal latency
Time Frame: 0 and 12 months

Nerve conduction studies of motor median nerve proximal latency (milliseconds)

Median nerve measurement points:

  • Distal: at the wrist, 8 cm proximal to the m. abductor pollicis brevis.
  • Proximal: at the cubital fossa
0 and 12 months
Nerve conduction studies: Motor median nerve amplitude
Time Frame: 0 and 12 months

Nerve conduction studies of motor median nerve amplitude (millivolts)

Median nerve measurement points:

  • Distal: at the wrist, 8 cm proximal to the m. abductor pollicis brevis.
  • Proximal: at the cubital fossa
0 and 12 months
Nerve conduction studies: Motor median nerve conduction velocity
Time Frame: 0 and 12 months

Nerve conduction studies of motor median nerve amplitude conduction velocity (meters per second)

Median nerve measurement points:

  • Distal: at the wrist, 8 cm proximal to the m. abductor pollicis brevis.
  • Proximal: at the cubital fossa
0 and 12 months
Nerve conduction studies: Motor ulnar nerve distal latency
Time Frame: 0 and 12 months

Nerve conduction studies of motor ulnar nerve distal latency (milliseconds)

Ulnar nerve measurement points:

  • Distal: at the wrist, 8 cm proximal to the abductor digiti minimi
  • Proximal: 3 cm distal to the medial epicondyle of the elbow
0 and 12 months
Nerve conduction studies: Motor ulnar nerve proximal latency
Time Frame: 0 and 12 months

Nerve conduction studies of motor ulnar nerve proximal latency (milliseconds)

Ulnar nerve measurement points:

  • Distal: at the wrist, 8 cm proximal to the abductor digiti minimi
  • Proximal: 3 cm distal to the medial epicondyle of the elbow
0 and 12 months
Nerve conduction studies: Motor ulnar nerve amplitude
Time Frame: 0 and 12 months

Nerve conduction studies of motor ulnar nerve amplitude (millivolts)

Ulnar nerve measurement points:

  • Distal: at the wrist, 8 cm proximal to the abductor digiti minimi
  • Proximal: 3 cm distal to the medial epicondyle of the elbow
0 and 12 months
Nerve conduction studies: Motor ulnar nerve conduction velocity
Time Frame: 0 and 12 months

Nerve conduction studies of motor ulnar nerve conduction velocity (meters per second)

Ulnar nerve measurement points:

  • Distal: at the wrist, 8 cm proximal to the abductor digiti minimi
  • Proximal: 3 cm distal to the medial epicondyle of the elbow
0 and 12 months
Nerve conduction studies: Sensory median nerve latency
Time Frame: 0 and 12 months

Nerve conduction studies of sensory median nerve latency (milliseconds)

Median nerve measurement points:

Palmar branch, 8 cm distance, 4th digit with 14 cm distance

0 and 12 months
Nerve conduction studies: Sensory median nerve amplitude
Time Frame: 0 and 12 months

Nerve conduction studies of sensory median nerve amplitude (microvolts)

Median nerve measurement points:

Palmar branch, 8 cm distance, 4th digit with 14 cm distance

0 and 12 months
Nerve conduction studies: Sensory median nerve conduction velocity
Time Frame: 0 and 12 months

Nerve conduction studies of sensory median nerve conduction velocity (meters per second)

Median nerve measurement points:

Palmar branch, 8 cm distance, 4th digit with 14 cm distance

0 and 12 months
Nerve conduction studies: Sensory ulnar nerve latency
Time Frame: 0 and 12 months

Nerve conduction studies of sensory ulnar nerve latency (milliseconds)

Ulnar nerve measurement points:

Palmar branch, 8 cm distance, 4th digit with 14 cm distance

0 and 12 months
Nerve conduction studies: Sensory ulnar nerve amplitude
Time Frame: 0 and 12 months

Nerve conduction studies of sensory ulnar nerve amplitude (microvolts)

Ulnar nerve measurement points:

Palmar branch, 8 cm distance, 4th digit with 14 cm distance

0 and 12 months
Nerve conduction studies: Sensory ulnar nerve conduction velocity
Time Frame: 0 and 12 months

Nerve conduction studies of sensory ulnar nerve conduction velocity (meters per second)

Ulnar nerve measurement points:

Palmar branch, 8 cm distance, 4th digit with 14 cm distance

0 and 12 months
Electromyography: Spontaneous activity
Time Frame: 0 and 12 months
Electromyography recording spontaneous activity in m.abductor pollicis brevis (Yes/No)
0 and 12 months
Electromyography: Chronic neurogenic changes
Time Frame: 0 and 12 months
Electromyography recording chronic neurogenic changes in m.abductor pollicis brevis (Yes/No)
0 and 12 months
Nerve conduction studies: Bland score
Time Frame: 0 and 12 months

Scoring of motor and sensory nerve conduction studies using the Bland scoring system (Bland, et al. 2000):

  • 0: normal
  • 1: very mild
  • 2: mild
  • 3: moderate
  • 4: severe
  • 5: very severe
  • 6: extremely severe
  • 7: not gradable
0 and 12 months
Semmes-Weinstein monofilament test
Time Frame: 0-24 months
Bilateral test of sensory function in digits 1,2 and 5 using a 2.83 monofilament. Graded absent/present.
0-24 months
Grip strength
Time Frame: 0-24 months
Test of grip strength using dynamometer. Range 0-90 kg.
0-24 months
Grip ability test (GAT)
Time Frame: 0-24 months
Simplified version of the Sollerman grip function test. Measures time for subject to perform 3 tasks: Pulling a tubular bandage over the hand, putting a paper clip on an envelope, and pouring water from a jar into a cup. Range 0-60 seconds for each task. Outcome measure is calculated as: tubular bandage (seconds) x 1.8 + paper clip on an envelope (seconds) + pouring water (seconds) x 1.8
0-24 months
Patient assessment of treatment effect on symptoms
Time Frame: 3-24 months
Patient-reported assessment of treatment effect on symptoms (current state compared to before treatment), reported on a 5-level ordinal (Likert) scale from 1 (best) to 5 (worst).
3-24 months
Patient assessment of expected treatment effect on symptoms
Time Frame: 0 months
Patient-reported expectation (reported by the patient prior to treatment) of the treatment's effect on symptoms, reported on a 5-level ordinal (Likert) scale from 1 (best) to 5 (worst).
0 months
Patient assessment of CTS symptoms
Time Frame: 0-24 months
Patient-reported assessment of CTS-related symptoms (current state), reported on a 5-level ordinal (Likert) scale from 1 (best) to 5 (worst).
0-24 months
Patient assessment of CTS-related functional impairment
Time Frame: 0-24 months
Patient-reported assessment of current CTS-related functional impairment (current state), reported on a 5-level ordinal (Likert) scale from 1 (best) to 5 (worst).
0-24 months
Patient assessment of acceptability of CTS-related symptoms and functional disability
Time Frame: 0-24 months
Patient assessment if the current CTS-related symptoms and functional disability are acceptable (yes or no)
0-24 months
Ultrasound measure of proximal cross-sectional area of the median nerve
Time Frame: 0-24 months
Bilateral evaluation of the proximal cross-sectional area of the median nerve (square millimeters) (as specified in protocol)
0-24 months
Ultrasound measure of distal cross-sectional area of the median nerve
Time Frame: 0-24 months
Bilateral evaluation of the distal cross-sectional area of the median nerve (square millimeters) (as specified in protocol)
0-24 months
Ultrasound measures of vascularity of the median nerve in the carpal tunnel
Time Frame: 0-24 months

Bilateral evaluation of vascularity of the median nerve in the carpal tunnel. Scored 0 to 3

  • 0: no PD signal
  • 1: 1 singular blood vessel
  • 2: 2-3 single blood vessels or 2 confluent
  • 3: ≥4 single blood vessels or ≥ 3 confluent
0-24 months
Disabilities of the Arm, Shoulder, and Hand (Quick-DASH)
Time Frame: 0-24 months

11-item patient reported outcome measure for disabilities of the arm, shoulder, and hand.

(Beaton DE, et al. 2005)

0-24 months
Patient pain assessment
Time Frame: 0-24 months
Patient-reported CTS-related pain on a 0-100 mm visual analogue scale (VAS), where 0 indicates no pain and 100 indicates worst possible pain.
0-24 months
Work Productivity and Activity Impairment Questionnaire (WPAI)
Time Frame: 0-24 months
Patient-reported outcome of physical function in work and activity. (Reilly MC, et al. 1993)
0-24 months
Days of work absence since start of intervention
Time Frame: 3-24 months
Number of days of work absence due to CTS or treatment of CTS since start of intervention
3-24 months
EuroQoL 5-dimension health-related quality of life (EQ5D-5L)
Time Frame: 0-24 months

EuroQoL 5-dimension patient-reported outcome for health-related quality of life.

(Herdman M, et al. 2011)

0-24 months
Adverse events
Time Frame: 0-24 months
Number and nature of adverse events and serious adverse events
0-24 months
Successful treatment after 1 corticosteroid injection
Time Frame: 3-24 months
Only applicable in the injection treatment strategy arm. Subjects who have received 1 corticosteroid injection who have attained a successful treatment result (Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5) without surgery
3-24 months
Successful treatment after 2 corticosteroid injections
Time Frame: 3-24 months
Only applicable in the injection treatment strategy arm. Subjects who have received 2 corticosteroid injections who have attained a successful treatment result (Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5) without surgery
3-24 months
Successful treatment after secondary surgery
Time Frame: 3-24 months
Only applicable in the injection treatment strategy arm. Subjects who have received 1 or 2 corticosteroid injections and secondary surgery who have attained a successful treatment result (Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5)
3-24 months
Undergone re-operation
Time Frame: 3-24 months

Subject have received a re-operation (yes/no)

A participant who for any reason requires a re-operation, either after primary surgery (surgery arm) or after corticosteroid injection therapy and delayed surgery (injection arm). Reasons for re-operation may, for instance, be wound complications or failure of the initial procedure.

NOTE: Secondary (delayed) surgery in a participant in the injection arm in accordance with the study treatment algorithm is not considered a re-operation.

3-24 months
Cost of treatment
Time Frame: 0-24 months
Direct treatment-associated costs, including hospital visits and procedures/interventions. Based on the diagnosis-related group (DRG) pricing system and codified price-lists for medical procedures.
0-24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of hospital services
Time Frame: 0-24 months
Use of hospital services from The Norwegian Patient Register (NPR)
0-24 months
Use of primary care resources
Time Frame: 0-24 months
Use of primary care resources based on data from Norwegian municipal patient- and user register (KPR)
0-24 months
Work participation
Time Frame: 0-24 months
Work participation based on data from Statistics Norways's (SSB) event database for social services (FD Trygd)
0-24 months
Total cost
Time Frame: 0-24 months
Unit costs will be assigned to each type of service by means of the diagnosis-related group (DRG) pricing system, and the price list of the Norwegian Medicines Agency. For each patient total costs will be estimated utilization of health care and social services. The mean symptom severity and cost in the two treatment arms will be used to estimate a cost-effectiveness ratio for the treatment strategies.
0-24 months
Environmental impact analysis
Time Frame: 0-24 months
Greenhouse gas emissions expressed as CO2 equivalents
0-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hilde B Hammer, MD, PhD, Diakonhjemmet Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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