NCT05915689

Brief Summary

Adhesive capsulitis is defined as a condition characterized by pain and stiffness in shoulder which results in both active and passive movement loss. The purpose of this study is to investigate the effects of shoulder directed treatment approach using Myofascial arm pull technique on the pain, range of motion and quality of life in patients with adhesive capsulitis and compare its effectiveness with Post Isometric Relaxation technique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

June 14, 2023

Last Update Submit

November 10, 2023

Conditions

Adhesive Capsulitis

Keywords

Adhesive Capsulitis, Pain, Shoulder, Joint Range of Motion

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale (NPRS)

    An NPRS is described as an 11-point scale with scores from 0 to 10 and anchors of 0 = no pain and 10 = worst possible pain Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in cervical spine. The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)

    6 weeks

  • SPADI(shoulder pain and disability index)

    The questionnaire consists of 13 items grouped into pain and disability subscales, the questions starting with "How severe is your pain." and "How much difficulty do you have.", respectively. Items mainly deal with various activities of daily living (ADL) that may or may not be problematic to the patient. Items are rated on visual analogue scales to produce a score for each subscale, and the means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst)

    6 weeks

Secondary Outcomes (1)

  • Universal Goniometer

    6 weeks

Study Arms (2)

Myofascial arm pull technique

EXPERIMENTAL

subjects in this group will be treated with myofascial arm pull technique

Other: Myofascial arm pull technique

Post Isomeric relaxation technique

EXPERIMENTAL

subjects in this group will be treated with post isometric relaxation technique

Other: post isometric relaxation technique

Interventions

Myofascial arm pull techniqueOTHER

patient in supine position move the arm passively in abduction to the restricted barrier and pull the arm only enough traction was used to counterbalance the weight of the patient's arm. Stretch was hold until the fibers were released, and then, stretch was given again by increasing traction. This sequence was repeated until an end feel was reached. same procedure for flexion and scapular protraction and Horizontal-adduction. Repetition will be 4-5 reps. per set, 3 times per week for 18 sessions.

Myofascial arm pull technique
post isometric relaxation techniqueOTHER

The therapist stood in front of the patient, then placed one hand over the top of the subject's involved shoulder. The therapist cups the gleno humeral joint to palpate for motion and the subjects are directed to press the elbow towards therapist hand for shoulder abduction, internal rotation and external rotation. Muscle energy technique was applied for five repetitions per set, five sets per session, one session per day, three days a week for six weeks with each repetition maintained for the duration of 7-10 second

Post Isomeric relaxation technique

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Unilateral frozen shoulder
  • male and female
  • Age between 40 and 60
  • grade 2 frozen shoulder with pain lasting more than three month;
  • capsular pattern of shoulder( External rotation, Abduction, Internal rotation)

You may not qualify if:

  • Acute inflammation
  • Subjects with systemic disease
  • Dislocation and fracture in and around the shoulder,
  • Rheumatoid arthritis
  • History of Subjects with diabetes mellitus, osteoporosis or malignancies in shoulder region
  • Past surgery around shoulder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hafeez clinic

Sialkot, Punjab Province, 51310, Pakistan

Location

Related Publications (6)

  • Rangan A, Brealey SD, Keding A, Corbacho B, Northgraves M, Kottam L, Goodchild L, Srikesavan C, Rex S, Charalambous CP, Hanchard N, Armstrong A, Brooksbank A, Carr A, Cooper C, Dias JJ, Donnelly I, Hewitt C, Lamb SE, McDaid C, Richardson G, Rodgers S, Sharp E, Spencer S, Torgerson D, Toye F; UK FROST Study Group. Management of adults with primary frozen shoulder in secondary care (UK FROST): a multicentre, pragmatic, three-arm, superiority randomised clinical trial. Lancet. 2020 Oct 3;396(10256):977-989. doi: 10.1016/S0140-6736(20)31965-6.

    PMID: 33010843BACKGROUND

  • Cho CH, Bae KC, Kim DH. Treatment Strategy for Frozen Shoulder. Clin Orthop Surg. 2019 Sep;11(3):249-257. doi: 10.4055/cios.2019.11.3.249. Epub 2019 Aug 12.

    PMID: 31475043BACKGROUND

  • Tedla JS, Sangadala DR. Proprioceptive neuromuscular facilitation techniques in adhesive capsulitis: a systematic review and meta-analysis. J Musculoskelet Neuronal Interact. 2019 Dec 1;19(4):482-491.

    PMID: 31789299BACKGROUND

  • Razzaq A, Nadeem RD, Akhtar M, Ghazanfar M, Aslam N, Nawaz S. Comparing the effects of muscle energy technique and mulligan mobilization with movements on pain, range of motion, and disability in adhesive capsulitis. J Pak Med Assoc. 2022 Jan;72(1):13-16. doi: 10.47391/JPMA.1360.

    PMID: 35099430BACKGROUND

  • Duzgun I, Turgut E, Eraslan L, Elbasan B, Oskay D, Atay OA. Which method for frozen shoulder mobilization: manual posterior capsule stretching or scapular mobilization? J Musculoskelet Neuronal Interact. 2019 Sep 1;19(3):311-316.

    PMID: 31475938BACKGROUND

  • Cohen C, Tortato S, Silva OBS, Leal MF, Ejnisman B, Faloppa F. Association between Frozen Shoulder and Thyroid Diseases: Strengthening the Evidences. Rev Bras Ortop (Sao Paulo). 2020 Aug;55(4):483-489. doi: 10.1055/s-0039-3402476. Epub 2020 Apr 6.

    PMID: 32904783BACKGROUND

MeSH Terms

Conditions

BursitisPain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sana Hafeez, PhD*

    Riphah International University Lahore Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 23, 2023

Study Start

March 3, 2023

Primary Completion

September 28, 2023

Study Completion

October 2, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)