Effect of Mechanical Interface Mobilization Technique on Pain and Functional Status in Carpal Tunnel Syndrome

September 16, 2024 updated by: Riphah International University
The aim of this study is to find out the influence of mechanical interface mobilization technique which consists of 5 different steps, in management of carpal tunnel syndrome and how this technique effects pain and functional status in individuals who has carpal tunnel syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The median nerve gets entrapped in the wrist, causing carpal tunnel syndrome (CTS), the most prevalent peripheral neuropathy in the upper limb. A number of clinical findings, such as sensory issues with the first three digits of the hand sensory distribution of the median nerve, a positive Phalen test, weakness and atrophy of the thenar muscle, and electrophysiological findings (prolonged motor and sensory distal latencies of the median nerve) are used to diagnose CTS . The most frequent occupational risk factors for CTS are repetitive wrist and finger motions or holding uncomfortable wrist positions for extended periods of time. Tenosynovitis of the finger flexors, a thicker transverse carpal ligament, a fracture or dislocation of the distal radius or lunate, rheumatoid arthritis, lipoma, diabetes, and hyperthyroidism are other non-occupational causes . A combination of techniques has been used in the studies of Seradge H. et al and Sucher Benjamin M. Et al which included mechanical interface and neuro-dynamics, but the isolated effects of each method is yet to be determined by further studies as their combined effects are more focused on in the current literature. And that leads to an unclear decision about, which group of manual therapy techniques has better effects on individuals suffering from CTS .

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Pakistan
    • Punjab
      • Khushāb, Punjab, Pakistan, 41000
        • Dhqh Campus 2 Khushab

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Positive Phalen test and Tinel Test.
  • Positive symptoms of CTS (Pain, numbness, or tingling in the first three and lateral half of the fourth finger.

Exclusion Criteria:

  • No previous surgical treatments at the wrist joint, no fractures or open wounds at the wrist.
  • Patients with thoracic outlet syndrome, and cervical radiculopathy.
  • History of carpal tunnel release surgery.
  • Steroid injection in the carpal tunnel.
  • Pregnant females.
  • Metabolic diseases such as diabetes, severe thyroid disorders and anemia.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mechanical Interface Mobilisation Technique
In the mechanical interface group, five techniques, including; wrist distraction (3 sets for 3 minutes), rhythmic and gentle stretching of the transverse carpal ligaments, release of palmar hand fascia, gliding of the finger flexor tendons (using oscillatory flexion-extension movement of metacarpophalangeal joint), and release of the upper forearm muscle and fascia will be applied. To release the upper forearm muscle as demonstrated for pronator teres muscle in, the therapist applied a firm pressure on the origin of the muscle by one thumb and concurrently moved the forearm into extension and supination (17).
Other: Mechanical Interface Mobilisation Technique
In the mechanical interface group, five techniques, including; wrist distraction (3 sets for 3 minutes), rhythmic and gentle stretching of the transverse carpal ligaments, release of palmar hand fascia, gliding of the finger flexor tendons (using oscillatory flexion-extension movement of metacarpophalangeal joint), and release of the upper forearm muscle and fascia will be applied. To release the upper forearm muscle as demonstrated for pronator teres muscle in, the therapist applied a firm pressure on the origin of the muscle by one thumb and concurrently moved the forearm into extension and supination (17).
Active Comparator: Exercise Therapy

Participants in this group will perform myofascial stretching of the carpal ligament, 3 days per week for four weeks along with isometric exercises at wrist joint as demonstrated by the physiotherapist.

The participants will be instructed to perform gentle, pain-free isometrics of the wrist and hand musculature (25). Exercise would be performed with 5-10-second hold, with 10 repetitions (26).
Other: Exercise Therapy

Participants in this group will perform myofascial stretching of the carpal ligament, 3 days per week for four weeks along with isometric exercises at wrist joint as demonstrated by the physiotherapist.

The participants will be instructed to perform gentle, pain-free isometrics of the wrist and hand musculature (25). Exercise would be performed with 5-10-second hold, with 10 repetitions (26).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS)
Time Frame: 4 week (will be measured at the end of every week)]
The VAS consists of a line, often 10 cm long, with verbal anchors at each end of the line, similar to a Numeric Rating Scale (i.e, no pain on the far left and severe pain on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.
4 week (will be measured at the end of every week)]
Symptom Severity Scale
Time Frame: 1st week(pre) and 4th week(post)]

Symptom Severity Scale (SSS) (24) The SSS consists of 11 items related to six domains said to be critical for the evaluation of CTS.

Each item is rated by the patient on a 1-5 (most severe) Likert scale, with higher ratings indicating more pain and disability.
1st week(pre) and 4th week(post)]
Hand functional status scale
Time Frame: 1st week(pre) and 4th week(post)]
Hand functional status scale (FSS) (24) The FSS consists of eight-items related to a variety of activities commonly performed by a diverse of patients. Each item is rated by the patient on a 1-5 (most severe) Likert scale, with higher ratings indicating more pain and disability.
1st week(pre) and 4th week(post)]

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Ramsha Tariq, MsOMPT, Riphah International University

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.

General Publications

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)

December 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCRAHS-ISB/REC/MS-PT/017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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