- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06110039
Comparative Effects of Cervicothoracic Junction Mobilization and Thoracic Manipulation in Subachromial Impinegment Syndrome
Comparative Effects of Cervicothoracic Junction Mobilization With Arm Movements and Upper Thoracic Manipulation in Patients With Subachromial Impinegment Syndrome
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: 051-5481826
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Imran Amjad, Phd
- Phone Number: +923324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Recruiting
- Johar pain relief center
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Contact:
- Mehreen Mazhar
- Phone Number: 03024702918
- Email: mehreenmazhar98@gmail.com
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Contact:
- Myda tahir
- Phone Number: 03371707011
- Email: jprc.lahore@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ranging from 18-40
- Both males and Females
- Positive Hawkins and Neer's impingement test positive
- The subjects primarily report unilateral shoulder pain.
Exclusion Criteria:
- Patients with diagnosed case of co morbidities such as malignancies, RA, or fracture, that causes bilateral shoulder discomfort.
- Diagnosed case of cervical radiculopathy, glenohumeral osteoarthritis, and adhesive capsulitis
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: Group 1: Cervicothoracic junction mobilization with arm movement along with baseline treatment
|
The therapist stood in back of the subject, who was seated straight on a chair.
The therapist positioned the medial side of one hand's thumb.
The desired level of vertebra can be strengthened by placing the index finger of the opposite hand on the spinous process.
A pure transverse glide was executed from the affected side to the unaffected side.
|
|
Experimental: Group 2: upper thoracic manipulation woth baseline treatment
|
The therapist placed one hand on the patient's head and the hypothenar or thenar eminence of the other hand was placed over the T1 transverse process (the therapist's left hand was used for thrusting and vice versa for treating the left T1 Transverse process).
As the tissue deficiency is taken up localizing the forces, the patient was urged to breathe in and out multiple times.
While holding the hand on the head steady, a minor relative rotation in the opposite direction was caused, which led to the introduction of the postero-anterior force on the transverse process of T1(29).
Patients will receive three sessions a week on alternate days for three weeks and follow up data will be taken once after completion of all three sessions using data collection tools
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 6 weeks
|
NPRS scale will be used to quantify pain intensity levels. The scale ranges from '0' for the least amount of pain "no pain" to '10' for the most extreme levels of pain "pain as severe as you can imagine". It is convenient to use NPRS for patients. Its score ranges between 0-10 (19). It is a valid and reliable tool (20). Reliability ranges from .67-.96 and validity ranges from 0.79-0.95 |
6 weeks
|
|
Shoulder pain and disability index SPADI
Time Frame: 6 weeks
|
To quantify the degree to which patients affected with shoulder pain may have disability the Shoulder Pain and Disability Index (SPADI) was created.
The SPADI's 13 components are split between a pain scale of five items and a disability scale of eight items.
The numerical rating scale variant was created to facilitate its use and scoring (23).
Reliability of SPADI is 0.92 and validity is 0.79
|
6 weeks
|
|
imagej software
Time Frame: 6 weeks
|
It can calculate area and pixel value statistics of user-defined selections.
It can measure distances and angles.
It can create density histograms and line profile plots.
It supports standard image processing functions such as contrast manipulation, sharpening, smoothing, edge detection and median filtering..
It has been introduced as a reliable assessment tool.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali Raza, Riphah International University
- Principal Investigator: Mehreen Mazhar, Riphah inernational university
Publications and helpful links
General Publications
- Michener LA, Kardouni JR, Sousa CO, Ely JM. Validation of a sham comparator for thoracic spinal manipulation in patients with shoulder pain. Man Ther. 2015 Feb;20(1):171-5. doi: 10.1016/j.math.2014.08.008. Epub 2014 Sep 6.
- Joshi S, Balthillaya G, Neelapala YVR. Immediate effects of cervicothoracic junction mobilization versus thoracic manipulation on the range of motion and pain in mechanical neck pain with cervicothoracic junction dysfunction: a pilot randomized controlled trial. Chiropr Man Therap. 2020 Aug 7;28(1):38. doi: 10.1186/s12998-020-00327-4.
- McDevitt A, Young J, Mintken P, Cleland J. Regional interdependence and manual therapy directed at the thoracic spine. J Man Manip Ther. 2015 Jul;23(3):139-46. doi: 10.1179/2042618615Y.0000000005.
- Lo YP, Hsu YC, Chan KM. Epidemiology of shoulder impingement in upper arm sports events. Br J Sports Med. 1990 Sep;24(3):173-7. doi: 10.1136/bjsm.24.3.173.
- Kardouni JR, Shaffer SW, Pidcoe PE, Finucane SD, Cheatham SA, Michener LA. Immediate changes in pressure pain sensitivity after thoracic spinal manipulative therapy in patients with subacromial impingement syndrome: A randomized controlled study. Man Ther. 2015 Aug;20(4):540-6. doi: 10.1016/j.math.2014.12.003. Epub 2014 Dec 22.
- McCoy RC, Bittencourt E, Clifton W. Cervicothoracic Manipulation Techniques Reviewed Utilizing Three-Dimensional Spine Model. Cureus. 2019 Oct 4;11(10):e5836. doi: 10.7759/cureus.5836.
- Hunter DJ, Rivett DA, McKiernan S, Luton R, Snodgrass SJ. Thoracic Manual Therapy Improves Pain and Disability in Individuals With Shoulder Impingement Syndrome Compared With Placebo: A Randomized Controlled Trial With 1-Year Follow-up. Arch Phys Med Rehabil. 2022 Aug;103(8):1533-1543. doi: 10.1016/j.apmr.2022.03.003. Epub 2022 Mar 21.
- Hegarty AK, Hsu M, Roy JS, Kardouni JR, Kutch JJ, Michener LA. Evidence for increased neuromuscular drive following spinal manipulation in individuals with subacromial pain syndrome. Clin Biomech (Bristol, Avon). 2021 Dec;90:105485. doi: 10.1016/j.clinbiomech.2021.105485. Epub 2021 Sep 21.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S22C14G30039
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.
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