Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation

August 19, 2022 updated by: Montecatone Rehabilitation Institute S.p.A.

A Randomized, Double Blind, Comparative Trial to Assess the Efficacy of Traditional Acupuncture vs Aspecific Needle Skin Stimulation for Persistent Pain in Subjects With Spinal Cord Injury

Pain is one of the most common problems in patients with spinal cord injury (SCI) and persistent pain (that can be of different origin: nociceptive, neuropathic or mixed) is often poorly responsive to pharmacological therapy. Attention has been paid to the use of non-pharmacological therapies and interventional techniques in treating pain in other clinical conditions, and acupuncture has been the treatment most used and appreciated for its effectiveness. However, only few studies are available on the use of acupuncture in SCI patients. The present randomized, comparative trial aims to clarify the efficacy of traditional acupuncture vs. aspecific needle skin stimulation in treating persistent pain in subjects with spinal cord injury, by overcoming the biases reported in previous studies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

About 67% of patients with spinal cord injury (SCI) experience painful symptoms in the course of life after injury and a third evaluates the pain as "severe", with a significant impact on quality of life, due to limitations in daily activities and autonomy. Persistent pain can be of different origin and may be nociceptive, neuropathic or mixed. However, it is often poorly responsive to pharmacological therapy. For some years, attention has been paid to the use of non-pharmacological therapies and interventional techniques in treating pain, and acupuncture has been the treatment most used and appreciated for its effectiveness. Only two studies on the use of acupuncture in SCI patients were included in the only Cochrane review available, dated 2014. Such studies, focusing on the painful shoulder syndrome and, therefore, on skeletal muscle pain, show a "non-superiority" of acupuncture compared to sham acupuncture treatment or Trager approach. However, the review does not come to any clear conclusions on the effectiveness of intervention because of the small number of cases and high risk of bias.

A more recent primary, randomized, controlled trial on SCI patients, although focusing on chronic pain and on a single acupuncture technique, uses a questionable study design (cross-over) to demonstrate treatment efficacy.

The present randomized, comparative trial aims to clarify the efficacy of traditional acupuncture vs. aspecific needle skin stimulation in treating persistent pain in subjects with spinal cord injury, by overcoming the biases reported in previous studies. Because of the intrinsic effects of sham acupuncture and, generally, of skin stimulation, a statistically significant change in the Numerical Rating Scale (NRS) measurements is expected even in the comparison group. To minimize this bias, which cannot be avoided, and to maintain the blindness of the patient as much as possible, the comparison group is treated by the insertion of needles in skin areas outside the metamer(s) affected by pain.

Primary objective:

- To evaluate the efficacy of traditional acupuncture vs. aspecific needle skin stimulation for persistent pain in subjects with spinal cord injury, at the end of treatment and at the 3 week follow-up.

Secondary objectives:

  • Reduction of drug intake, at the end of treatment and at the subsequent follow-up;
  • Reduction of anxiety/depression, at the end of treatment and at the subsequent follow-up;
  • Improvement of quality of life, at the end of treatment and at the subsequent follow-up;
  • Persistence of the effect of acupuncture 9 weeks after treatment.

Data concerning any adverse events, related to both experimental treatments of the trial, will also be collected.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Italy
    • BO
      • Imola, BO, Italy, 40026
        • Montecatone Rehabilitation Institute S.p.A.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persistent pain: NRS score >2 in at least 5 assessments in 5 consecutive days, despite usual antalgic management;
  • Spinal cord injury due to any etiology (both traumatic and non-traumatic);
  • Spinal cord injury of any neurological level, complete or incomplete, classifiable as Asia Impairment Score (AIS) A, B, C or D;
  • Stable medical conditions;
  • At least 1 month away from the spinal cord injury event.

Exclusion Criteria:

  • Sporadic pain;
  • Mechanical ventilation;
  • Pregnancy;
  • Disorders of consciousness;
  • Incapacity to give informed consent in person.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Traditional chinese acupuncture
Traditional chinese acupuncture. Administration of 12 sessions (2 per week for 6 weeks). Each session lasts 20-30 minutes.
Other: Traditional chinese acupuncture
Traditional chinese acupuncture (somatopuncture points, auriculotherapy points, craniopuncture and wrist-ankle acupuncture). Simultaneously, the usual pharmacological treatment for pain is maintained, based on clinical needs.
Sham Comparator: Aspecific needle skin stimulation
Aspecific needle skin stimulation. Administration of 12 sessions (2 per week for 6 weeks). Each session lasts 20-30 minutes.
Other: Aspecific needle skin stimulation
Superficial needling of needles in skin areas outside the pain affected dermatome(s). Simultaneously, the usual pharmacological treatment for pain is maintained, based on clinical needs.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain reduction
Time Frame: Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)
Pain reduction of at least 2 points on the NRS scale
Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Persistence of pain reduction in Acupuncture arm
Time Frame: Follow-up 2 (9 weeks after closing session 12)
Pain reduction of at least 2 points on the NRS scale
Follow-up 2 (9 weeks after closing session 12)
Reduction of drugs intake
Time Frame: Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12); follow-up 2 (9 weeks after closing session 12)
Intake reduction of antalgic, hypnotic and anxiolytic drugs (number and dosage)
Baseline (initial visit); session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12); follow-up 2 (9 weeks after closing session 12)
Reduction of Anxiety/Depression
Time Frame: Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12); follow-up 2 (9 weeks after closing session 12)
Reduction of anxiety/depression symptoms, assessed by Hospital Anxiety and Depression Scale
Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12); follow-up 2 (9 weeks after closing session 12)
Reduction of pain interference on sleep and quality of life
Time Frame: Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)
Reduction of pain interference on sleep and quality of life, assessed by Multidimensional Pain Inventory scale, Part 1
Baseline (initial visit); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)
Improvement of quality of life
Time Frame: Baseline (initial visit); closing session 12 (6 weeks); follow-up 2 (9 weeks after closing session 12)
Increase of participation in family and social life, assessed by Multidimensional Pain Inventory scale, Part 2
Baseline (initial visit); closing session 12 (6 weeks); follow-up 2 (9 weeks after closing session 12)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: Closing session 12 (6 weeks)
Assessment of patient satisfaction after antalgic treatment by an in-house developed ad-hoc questionnaire
Closing session 12 (6 weeks)
Adverse events
Time Frame: Session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)
Recording possible adverse events attributable to the experimental treatments
Session 6 (3 weeks); closing session 12 (6 weeks); follow-up 1 (3 weeks after closing session 12)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Montecatone Rehabilitation Institute S.p.A.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Associazione Medici Agopuntori Bolognesi (A.M.A.B.)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Angela Morreale, MD, Montecatone Rehabilitation Institute S.p.A.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CE-17017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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