- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06407817
Comparative Effects Of Spencer and Reverse Distraction Technique In Patients With Adhesive Capsulitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adhesive capsulitis, also known as frozen shoulder, is an inflammatory condition characterized by shoulder stiffness, pain, and significant loss of passive range of motion. Adhesive capsulitis has a prevalence of approximately 2% to 5% in the general population, with a mean onset of age of 55.
A randomized clinical trial will be conducted at Ibne Sina Hospital, Multan . Non probability convenience sampling technique will be applied on 50 patients who will be allocated through computerized randomization into group A & group B to collect data. Group A will be given spencer technique and group B will be given reverse distraction technique along with baselines. The study will be completed within the time duration of ten months. Primary Outcome measures of the research will be pain, range of motion, function, muscle strength, disability and quality of life will be measured pre and post intervention. The whole treatment protocols will be given for four weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rabiya Noor, phd
- Phone Number: 03344355660
- Email: Rabiya.Noor@riphah.edu.pk
Study Contact Backup
- Name: Minal Mushtaq, MS-DPT
- Phone Number: 03314662231
- Email: minalmustafakhan@gmail.com
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54782
- Recruiting
- Johar pain relief center
-
Contact:
- Rabiya Noor, phd
- Phone Number: 03344355660
- Email: Rabiya.Noor@riphah.edu.pk
-
Principal Investigator:
- Minal Mushtaq, MS(OMPT)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age group 40-60 years
- Male and female
- Positive Capsular pattern (ER more limited than Abd which is more limited than IR)
- Limitation in shoulder ROM ; Flexion <180 , Abduction <180 , External Rotation <50
- Patients of stage 2 and 3 of adhesive capsulitis
Exclusion Criteria:
- History of surgery of the affected shoulder
- Fractures in around the shoulder
- Neurological disorders leading to altered muscle activity
- Systemic arthritic conditions (RA, Osteoporosis)
- Disorders of 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: Spencer's technique
This group will receive the Spencer's technique.
|
No of repetitions; 3 sets for 10 repetitions with 1 minute rest between sets No Of Sessions Per Week: 3 Per Weeks for 6 weeks (40 Min per Session)
No of repetitions; 10 ( Shoulder Abduction)10 ( Shoulder Flexion) 10 (Shoulder External Rotation) No Of Sessions Per Week: 3 Per Weeks for 6 weeks (40 Min Per Session)
|
|
Active Comparator: reverse distraction technique
This group will recieve reverse distraction technique
|
No of repetitions; 3 sets for 10 repetitions with 1 minute rest between sets No Of Sessions Per Week: 3 Per Weeks for 6 weeks (40 Min per Session)
No of repetitions; 10 ( Shoulder Abduction)10 ( Shoulder Flexion) 10 (Shoulder External Rotation) No Of Sessions Per Week: 3 Per Weeks for 6 weeks (40 Min Per Session)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain : numerical pain rating scale
Time Frame: 6 weeks
|
Patients' overall assessment of pain will be provided using the numeric pain rating scale (NPRS).
The NPRS is known to be a sensitive and reliable scale for clinical and experimental evaluation of pain intensity.
The score ranges from 0, indicating no pain, to 10, expressing worst imaginable pain.
The reliability of numeric pain rating scale (NPRS) is 0.92 (0.87, 0.95).
|
6 weeks
|
|
range of motion : universal goniometer
Time Frame: 6 weeks
|
Universal Goniometer is the most commonly utilised clinical tool for measuring joint range of motion due to its ease of use, low cost, and demonstrated reasonable levels of reliability and validity in numerous studies.
Validity and intertester reliability (r =.97-.98;
ICC =.98-.99)
are both high
|
6 weeks
|
|
shoulder pain and impairment : SPADI
Time Frame: 6 weeks
|
The SPADI consists of 13 items that assess two domains: a 5-item subscale for pain and an 8-item subscale for disability. The SPADI has since been used in both primary care on mixed diagnosis and surgical patient populations including rotator cuff disease, osteoarthritis, and rheumatoid arthritis, adhesive capsulitis ,joint replacement surgery , and in a large population-based study of shoulder symptoms (37). Reliability- 0.89, Validity - 0.90 |
6 weeks
|
|
36-Item Short Form Health Survey questionnaire (SF-36)
Time Frame: 6 weeks
|
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life.
The ICC for SF-36 PF is (0.96, 95% CI 0.92-0.98)
so it's a reliable test.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rabiya Noor, PhD, 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 (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/23/0184
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
product manufactured in and exported from the U.S.
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 Adhesive Capsulitis
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Daniel G. RendeiroCompletedAdhesive Capsulitis of Shoulder | Frozen Shoulder | Shoulder Adhesive CapsulitisUnited States
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University of MalayaNot yet recruitingAdhesive Capsulitis of Shoulder
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Taipei Veterans General Hospital, TaiwanRecruitingAdhesive Capsulitis of ShoulderTaiwan
-
Cairo UniversityNot yet recruitingAdhesive Capsulitis of Shoulder
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Health Education Research Foundation (HERF)RecruitingAdhesive Capsulitis of ShoulderPakistan
-
Taif UniversityCompletedAdhesive Capsulitis of ShoulderSaudi Arabia
-
Riphah International UniversityCompletedAdhesive Capsulitis of ShoulderPakistan
-
Balikesir UniversityCompletedAdhesive Capsulitis of Shoulder
-
Haytham M ElhafezCairo UniversitySuspendedAdhesive Capsulitis of the ShoulderEgypt
-
Superior UniversityActive, not recruitingAdhesive Capsulitis, ShoulderPakistan
Clinical Trials on Spencer technique
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Cairo UniversityNot yet recruiting
-
Riphah International UniversityNot yet recruitingAdhesive Capsulitis | Frozen ShoulderPakistan
-
Superior UniversityActive, not recruitingAdhesive Capsulitis, ShoulderPakistan
-
Lake Erie College of Osteopathic MedicineLake Erie College of Osteopathic Medicine (LECOM)Completed
-
Superior UniversityActive, not recruiting
-
Riphah International UniversityCompletedAdhesive CapsulitisPakistan
-
Riphah International UniversityNot yet recruitingSports Physical TherapyPakistan
-
Riphah International UniversityCompleted
-
Riphah International UniversityCompletedAdhesive CapsulitisPakistan
-
Foundation University IslamabadRecruitingAdhesive CapsulitisPakistan