- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06707857
Effects of TNT on Pain, ROM and Disability in Patients With RC Tendinopathy
Effects of Tendon Neuroplastic Training on Pain, Range of Motion and Disability in Patients With Rotator Cuff Tendinopathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Recruiting
- Riphah Rehabilitation Clinic
-
Contact:
- Ali Raza, MS-OMPT
- Phone Number: 0332 6099065
-
Sub-Investigator:
- Sheeza kalsoom, MS-OMPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Have a current shoulder complaint lasting at least three months prior to the time of enrollment
- Pain is located in the proximal lateral aspect of the upper arm (C5 dermatome)
- Positive Hawkins-Kennedy test
Exclusion Criteria:
- Bilateral shoulder pain
- Less than 90 degrees of active elevation of the arm
- Corticosteroid injection within the last six weeks
- Radiologically verified fracture
- Glenohumeral osteoarthritis
- Surgery or dislocation of the affected shoulder
- Symptomatic arthritis in the Ac joint
- Frozen shoulder
- Symptoms derived from the cervical spine
Study Plan
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 |
|---|---|
|
Experimental: Tendon neuroplastic training
Group A will be treated with tendon neuroplastic training. The exercise involved isolated abduction external rotation ,internal rotation and flexion paced to an external audio cue on the patients' smartphone The patient was to listen to the sound and track the movement of the metronome with his eyes, as pacing to these types of external cues has been shown to modulate conspiratorial excitability.The pace of the metronome was set to 6 beats per minute such that each beat was ten seconds apart. This allowed a ten second isometric, eccentric and concentric phase, in 30 seconds totally. Three sets of 10 repetitions of slow progressive exercises (eccentric, concentric and isometric respectively) of the wrist rotator cuff muscles at each treatment session were performed, with 1-min rest interval between each set. The patient followed the supervised exercise programme 3 times a week for 6 weeks |
Throughout the training, participants pain, range of motion and disability were monitored and they were asked to report any discomfort or unusual sign.
|
|
Active Comparator: Conventional training
Group B will be treated with conventional therapy Participants will perform isometric contraction of the arm at 90° of elevation in the scapular plane.
External and internal rotation, respectively) will be performed in the same positions of isometric strength assessment.Individuals will perform three sets, sustained for 32 s, at 70% of maximal voluntary isometric contraction (MVIC), resting for 80 seconds between sets.Resistance load will be determined according to maximal isometric strength of elevation and external and internal rotations measured during the pre-intervention assessment
|
Throughout the training, participants pain, range of motion and disability were monitored and they were asked to report any discomfort or unusual sign.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain rate scale (NPRS)
Time Frame: 6 weeks
|
Patient level of pain will be assessed using this scale.
This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain".
|
6 weeks
|
|
Shoulder pain and disability index (spadi)
Time Frame: 6 weeks
|
Patient level of disability will be assessed using this scale.
This ranges from 0 to 100.
0 indicates no disability" and 100 indicates disability"
|
6 weeks
|
|
Universal Goniometer (UG)
Time Frame: 6 weeks
|
It will measure range of motion of shoulder
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saba Rafique, MS-OMPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/0111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Rotator Cuff Tendinopathy
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-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingRotator Cuff Tendinopathy
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Shin Kong Wu Ho-Su Memorial HospitalCompletedRotator Cuff Tear | Ultrasonography | Rotator Cuff TendinopathyTaiwan
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University of Alabama at BirminghamTerminatedPartial Tear of Rotator Cuff | Tendinopathy of Rotator CuffUnited States
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Ankara City Hospital BilkentNot yet recruitingChronic Shoulder Pain | Rotator Cuff TendinopathyTurkey (Türkiye)
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InGeneron, Inc.Active, not recruitingRotator Cuff Tear | Rotator Cuff TendinitisUnited States
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The Foundation for Orthopaedics and Regenerative...WithdrawnRotator Cuff Tears | Rotator Cuff TendinitisUnited States
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Sutherland Medical CenterActive, not recruitingRotator Cuff Tears | Rotator Cuff TendinosisPoland
-
National Taiwan University HospitalUnknownRotator Cuff Tears | Rotator Cuff TendinosisTaiwan
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Istanbul Training and Research HospitalCompletedSupraspinatus TendinopathyTurkey