- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05524870
The Effect of Manual Therapy on Central Sensitization
November 15, 2023 updated by: Volkan Deniz, PT, Cukurova University
Movement With Mobilization Technic Plus Exercising Versus Exercising Alone for Central Sensitization in Patients With Subacromial Pain: a Sham-controlled Randomized Clinical Trial
Subacromial pain syndrome (SIS) is a common cause of shoulder pain, estimated to be the cause for up to half of incident cases.
Typically, pain is generated with elevation of the arm above the head though it can occur with rest in patients with SIS.There is evidence of central sensitization in those who experience chronic shoulder pain from SIS. Central sensitization is an augmentation of the nociceptive pathways of the central nervous system that is characterized by local and generalized lowered pain thresholds and an exaggerated pain response to painful and non painful stimulation.Mobilization with movement (MWM) technic is a kind of manual therapy and it is often used by clinicians for the treatment of musculoskeletal diseases.
Usually manual therapy is used for its peripheral effects, however it also produces central analgesic effects activating descending anti-nociceptive pathways for a short period of time (30 - 35 mins.).
Some speculate that repeated sessions of manual therapy may result in a long term activation of descending anti-nociceptive pathways.
However, there is no evidence of this mechanism available yet.
Therefore, the aim of this study is to investigate the effect of MWM on central sensitization (primary aim) and shoulder functions (secondary aim) in patients with SIS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
63
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
-
-
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Adana, Turkey
- Cukurova University
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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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- To have confirmed unilateral subacromial pain (positive testing at Neer Impingement and Hawkins-Kennedy tests),
- To have <40 score in central sensitization inventory.
Exclusion Criteria:
- To have bilateral subacromial pain,
- To have any pathology (except subacromial pain) that give rise to central sensitization (This pathologies are summarized in central sensitization inventory - part B)
- To have severe osteoarthritis or subluxation in shoulder joint,
- To have adhesive capsulitis,
- Being treated with physiotherapy for this disorder at least one month before the start of the study.
- To have severe cervical or lumbar radiculopathy,
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: Mobilization
Mobilization with movement plus exercise.
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Movement with mobilization plus exercise
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Placebo Comparator: Sham mobilization
Sham mobilization with movement plus exercise
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Movement with mobilization plus exercise
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Active Comparator: Control
Exercise alone
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Movement with mobilization plus exercise
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Central Sensitization Inventory
Time Frame: Baseline, 3 weeks: change from baseline central sensitization at 3 weeks, 3 months: change from central sensitization at 3 months.
|
The central sensitization inventory (CSI), a patient reported outcome measure, is a reliable and valid comprehensive screening instrument for identification of central sensitization.
The CSI inventory comprises of two sections - Part A and Part B. Part A consisted of 25-item self-report questionnaire with each item assessed on a 5-point Likert scale (0=never and 4=always), with total scores ranging from 0-100.
Part B evaluates health-related symptoms that are common to central sensitization syndromes.Higher scores indicate more severe central sensitization.
A CSI cut-off score of 40 exhibited good sensitivity in identifying central sensitization.
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Baseline, 3 weeks: change from baseline central sensitization at 3 weeks, 3 months: change from central sensitization at 3 months.
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Pressure-Pain Threshold-Algometer
Time Frame: Baseline, 3 weeks: change from baseline pressure pain threshold at 3 weeks, 3 months: change from pressure pain threshold at 3 months.
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Pressure pain threshold (PPT) is defined as the minimal amount of pressure where a sense of pressure first changes to pain.
A mechanical pressure algometer is used in this study to assess PPT.
This device consists of a round rubber disk (area,1 cm2 ) attached to a pressure (force) gauge.
The gauge displays values in kilograms.
Because the surface of the rubber tip is 1 cm2, the readings are expressed in kilograms per square centimeter.
The range of the algometer is 0 to 10 kg with 0.1-kg divisions.
Higher scores indicate high PPT.
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Baseline, 3 weeks: change from baseline pressure pain threshold at 3 weeks, 3 months: change from pressure pain threshold at 3 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quick Disabilities of the Shoulder, Arm and Hand Questionnaire
Time Frame: Baseline, 3 weeks: change from baseline shoulder functions at 3 weeks, 3 months: change from shoulder functions at 3 months.
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The Quick Disabilities of the Shoulder, Arm and Hand Questionnaire assesses physical functioning and symptoms of the upper limb, yielding a result between 0 and 100% (0% being the best and 100% being the worst outcomes).
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Baseline, 3 weeks: change from baseline shoulder functions at 3 weeks, 3 months: change from shoulder functions at 3 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 15, 2022
Primary Completion (Actual)
February 1, 2023
Study Completion (Actual)
February 5, 2023
Study Registration Dates
First Submitted
August 30, 2022
First Submitted That Met QC Criteria
August 30, 2022
First Posted (Actual)
September 1, 2022
Study Record Updates
Last Update Posted (Estimated)
November 17, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 107/82
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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