- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07921017
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Effects of Cervicothoracic Mobilization on Shoulder Pain, Range of Motion, and Disability in Patients With Supraspinatus Tendinitis
This study aims to evaluate the effects of cervicothoracic junction mobilization on pain, shoulder range of motion (ROM), and disability in patients with supraspinatus tendinitis. A randomized controlled trial will include 62 participants divided into experimental and control groups. The experimental group will receive cervicothoracic mobilization alongside conventional physiotherapy, while the control group will receive conventional physiotherapy only. Outcomes will be assessed using NPRS, a goniometer, and SPADI. Data will be analyzed using IBM SPSS, with results reported after data collection and analysis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Supraspinatus tendinitis is a frequent cause of shoulder pain and functional impairment and may be influenced by dysfunction in the cervicothoracic region. Mobilization of the cervicothoracic junction has been suggested to improve shoulder symptoms by enhancing regional mobility and neuromuscular control; however, evidence in patients with supraspinatus tendinitis remains limited. This study will evaluate the effects of cervicothoracic junction mobilization on shoulder pain, range of motion (ROM), and disability in patients with supraspinatus tendinitis. A randomized controlled trial will be conducted with 62 participants diagnosed with supraspinatus tendinitis, recruited via convenience sampling after written informed consent. Participants will be randomly allocated into two groups (31each) using a computer-generated sequence by a blinded assistant, concealed in opaque envelopes. Group A (Experimental) will receive cervicothoracic mobilization (C6T4) using Maitland's Grade III-IV central PA and transverse oscillatory techniques, alongside conventional physiotherapy. Group B (Control) will receive conventional physiotherapy only, including moist heat (10 min), Codman's pendulum, stretching, scapular setting, and open-chain TheraBand resistance exercises. Outcomes-pain (NPRS), shoulder range of motion (goniometer), and disability (SPADI)-will be assessed at baseline and post-intervention. Data will be analyzed using an independent t-test in IBM SPSS, with significance set at p < 0.05. Will be given after Data Collection.
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
-
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54700
- Recruiting
- Itefaq Hospital and PMC by Dr. Waqar Ali
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Contact:
- Dr. Ali Raza, MS
- Phone Number: 03326099065
- Email: dralirazapt@gmail.com
-
Principal Investigator:
- Zarish Fatima, MS OMPT
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Sub-Investigator:
- Ali Raza, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female patients both are included age ranging from 25 to 45 years.
- Diagnosis confirmed through Jobe's Test (Empty can) and characteristic signs and symptoms of supraspinatus tendinitis.
Exclusion Criteria:
- History of any previous surgical intervention involving the shoulder.
- Shoulder joint instability due to causes other than supraspinatus pathology.
- Presence of acromioclavicular joint arthritis.
- Participants were excluded if they had osteoporosis, spinal fractures, or tumors.
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: Cervicothoracic Junction Mobilization
This group will receive Maitland-based rhythmic oscillatory mobilizations, including central posterior-anterior and transverse techniques applied to the cervicothoracic region (C6-T4). |
Participants will receive Maitland-based rhythmic oscillatory mobilizations, including central posterior-anterior and transverse techniques applied to the cervicothoracic region (C6-T4), on every alternate day in addition to the same physiotherapy program provided to the control group over six weeks. |
|
Active Comparator: Traditional physiotherapy
A standard physical therapy protocol is given to the participants in this group |
Cryotherapy for 10 minutes for the first 2 days. Codman exercises: 10 repetitions of each movement, 3 days/week, a strengthening protocol for the rotator cuff muscles and scapula. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 4rth week
|
It is a scale to measure pain, where 0 indicates no pain, and 10 indicates the worst pain possible. |
4rth week
|
|
Shoulder Pain And Disability Index (SPADI)
Time Frame: 4rth week
|
The Shoulder Pain and Disability Index (SPADI) is a self-reported questionnaire used to assess shoulder pain and disability in daily activities. It consists of 13 items divided into two subscales: pain (5 items) and disability (8 items), with higher scores indicating greater pain and functional limitation. |
4rth week
|
|
ROM Shoulder (Abduction)
Time Frame: 4rth week
|
Changes from ROM of Shoulder Abduction were taken with the help of a goniometer |
4rth week
|
|
ROM Shoulder (external rotation)
Time Frame: 4rth week
|
Changes from ROM of Shoulder External rotation were taken with the help of a goniometer |
4rth week
|
|
ROM shoulder (Flexion)
Time Frame: 4rth week
|
Changes from ROM of Shoulder Flexion were taken with the help of a goniometer |
4rth week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali Raza, Mphill, Riphah International University
Publications and helpful links
General Publications
- Bergman GJ, Winters JC, Groenier KH, Pool JJ, Meyboom-de Jong B, Postema K, van der Heijden GJ. Manipulative therapy in addition to usual medical care for patients with shoulder dysfunction and pain: a randomized, controlled trial. Ann Intern Med. 2004 Sep 21;141(6):432-9. doi: 10.7326/0003-4819-141-6-200409210-00008.
- Vila-Dieguez O, Heindel MD, Awokuse D, Kulig K, Michener LA. Exercise for rotator cuff tendinopathy: Proposed mechanisms of recovery. Shoulder Elbow. 2023 Jun;15(3):233-249. doi: 10.1177/17585732231172166. Epub 2023 May 4.
- Liu S, Chen L, Shi Q, Fang Y, Da W, Xue C, Li X. Efficacy of manual therapy on shoulder pain and function in patients with rotator cuff injury: A systematic review and meta-analysis. Biomed Rep. 2024 Apr 11;20(6):89. doi: 10.3892/br.2024.1778. eCollection 2024 Jun.
- Spargoli G. SUPRASPINATUS TENDON PATHOMECHANICS: A CURRENT CONCEPTS REVIEW. Int J Sports Phys Ther. 2018 Dec;13(6):1083-1094.
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
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/25/0185
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
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