Comparison of PFS and ART in Adhesive Capsulitis in Diabetic Patients

Sponsor
Riphah International University (Other)
Overall Status
Completed
CT.gov ID
NCT04561310
Collaborator
(none)
36
1
2
7.5
4.8

Study Details

Study Description

Brief Summary

To determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques

Condition or Disease Intervention/Treatment Phase
  • Other: Post facilitation stretch
  • Other: Active release technique
N/A

Detailed Description

There is a very limited literature available Active release technique (ART) and Post Facilitation Stretch (PFS) in frozen shoulder. Additionally there is a very limited literature on the evaluation of ART in comparison with PFS in adhesive capsulitis of diabetic patient. Disease such as rheumatoid arthritis (RA), osteoarthritis (OA) etc that cause stiffness of the shoulder joint also present with altered muscle activity, that in long run becomes one of the main causes of reduces joint range of motion. With this study, we will be able to determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques. This study will also fulfill that research gap and will provide clinicians with an alternative approach in treatment of adhesive capsulitis.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison of Post Facilitation Stretch and Active Release Technique in Adhesive Capsulitis in Diabetic Patients
Actual Study Start Date :
Jun 15, 2020
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Post facilitation stretch

Post facilitation stretch with Maitland mobilization

Other: Post facilitation stretch
Post facilitation stretch with maitland mobilization Grade I & II Maitland mobilization of shoulder joint in 1st and 2nd week progressing to Grade III oscillatory mobilization of shoulder joint in 3rd week. It will further progress to Grade IV Maitland oscillatory mobilizations in the 4th or 5th week. Treatment will be provided 3 session/week for 6 weeks with 40 minutes/session

Active Comparator: Active release technique

Active release technique with Maitland mobilization

Other: Active release technique
Active release technique with maitland mobilization Grade I & II Maitland mobilization of shoulder joint in 1st and 2nd week progressing to Grade III oscillatory mobilization of shoulder joint in 3rd week. It will further progress to Grade IV Maitland oscillatory mobilizations in the 4th or 5th week. Treatment will be provided 3 session/week for 6 weeks with 40 minutes/session

Outcome Measures

Primary Outcome Measures

  1. Shoulder pain and disability Index (SPADI) [6th week]

    The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. Each of the 13 items is to be rated with a number from 0 to 10: For the pain score (first 5 items): 0 means no pain and 10 means worst pain imaginable; For the disability score (last 8 items): 0 means no impairment and 10 means the patient requires help to perform that action

  2. The oxford scale [6th week]

    The Oxford Scale is a 0-5 scale which is then recorded as 0/5 or 2/5, sometimes with a + or - sign to indicate more or less power but not sufficient to reduce or increase the number.

  3. Numeric Pain Rating Scale (NPRS) [6th week]

    The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.

  4. ROM Shoulder Flexion [6th week]

    Goniometer is used to measure the range of the motion of the shoulder flexion

  5. ROM Shoulder Extension [6th week]

    Goniometer is used to measure the range of the motion of the shoulder extension

  6. ROM Shoulder Abduction [6th week]

    Goniometer is used to measure the range of the motion of the shoulder Abduction

  7. ROM Shoulder External Rotation [6th week]

    Goniometer is used to measure the range of the motion of the shoulder External Rotation

  8. ROM Shoulder Internal Rotation [6th week]

    Goniometer is used to measure the range of the motion of the shoulder Internal Rotation

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Controlled diabetic patients (random 200-250mg/dl /fasting 120-160mg/dl).

  • Grade 2 & 3 of adhesive capsulitis,

  • Pain (NPRS) ranging between 3-10

  • Reduced normal shoulder ROM's i.e

  • Flexion less than 160 degrees.

  • Extension less than 50 degrees.

  • Abduction less than 170 degrees.

  • External rotation less than 80 degrees.

  • Internal rotation less than 70 degrees

Exclusion Criteria:
  • Trauma history of shoulder/surgery.

  • Frozen shoulder accompanied with neurological involvement.

  • People with any injury or disability of elbow or hand

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asif Hospital Wah Cantt Islamabad Punjab Pakistan

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Nazish Rafique, MSPT, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT04561310
Other Study ID Numbers:
  • REC/00241 Ummal Baneen
First Posted:
Sep 23, 2020
Last Update Posted:
Mar 24, 2021
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2021