Comparative Effects Of Spencer and Reverse Distraction Technique In Patients With Adhesive Capsulitis

December 20, 2024 updated by: Riphah International University
To compare the effects of spencer and reverse distraction technique in patients with adhesive capsulitis

Study Overview

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

Interventional

Enrollment (Estimated)

50

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 Contact

Study Contact Backup

Study Locations

    • Punjab
      • Lahore, Punjab, Pakistan, 54782
        • Recruiting
        • Johar pain relief center
        • Contact:
        • Principal Investigator:
          • Minal Mushtaq, MS(OMPT)

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

  • Adult

Accepts Healthy Volunteers

No

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rabiya Noor, PhD, Riphah International University

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 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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