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Clinical Trials/NCT06407817
NCT06407817RecruitingNot Applicable

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

Riphah International University2 sites in 1 country50 target enrollmentStarted: February 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
50
Locations
2
Primary Endpoint
shoulder pain and impairment : SPADI

Study Overview

Brief Summary

To compare the effects of spencer and reverse distraction technique in patients with adhesive capsulitis

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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.

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).

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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