NCT05151783

Brief Summary

Adhesive capsulitis is painful movement restricted condition linked with pain, restricted range of motion and difficulty in performing daily life activities. Multiple treatment options are there for its treatment. However, role of peripheral neuromuscular facilitation in this regimen is still under consideration.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

November 4, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

December 10, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1 month

First QC Date

November 4, 2021

Last Update Submit

November 25, 2021

Conditions

Keywords

adhesive capsulitisscapular PNF techniqueshoulder range of motion

Outcome Measures

Primary Outcomes (4)

  • change in pain intensity

    pain measured by visual analogue scale where o represents no pain and 10 represents severe pain

    Baseline data will be collected and then at 2nd week and 4th week.

  • change in shoulder Range of motion

    shoulder range of motion through goniometer

    Baseline data will be collected and then at 2nd week and 4th week.

  • change in shoulder functional activities

    shoulder functional activities by simple shoulder function test

    Baseline data will be collected and then at 2nd week and 4th week.

  • change in scapular mobility

    scapular mobility through lateral scapular slide test

    Baseline data will be collected and then at 2nd week and 4th week.

Study Arms (2)

conventional physiotherapy

ACTIVE COMPARATOR

routine physical therapy for adhesive capsulitis

Other: conventional physiotherapy

PNF techniques

EXPERIMENTAL

PNF techniques along with conventional physiotherapy

Other: PNF technique

Interventions

Control group receivewill routine physical therapy including modalities like ultrasound (3 MHz continuous type; duration 10 minutes), heat modalities (apply to the involved region of shoulder joint shoulder for 10 minutes), shoulder ROM exercises, capsular stretching, and joint mobilization 5 times per week for four weeks. Duration of session will be 40 minutes. All Maitland mobilization will be given in supine position. After giving glenohumeral (GH) joint distraction, GH caudal glide, GH dorsal glide, and GH ventral glide were given at a rate of 2-3/second oscillations for 1-2 minutes to patients. Grade I or II rhythmic oscillations will be applied in pain free movement.

conventional physiotherapy

Group will receive scapular PNF techniques with routine physical therapy explained above For PNF techniques, patients will be lying on unaffected shoulder. In this group, 20 repetitions of diagonal scapular Pattern (Anterior Elevation and Posterior Depression and Posterior Elevation and Anterior Depression) with 20 sec rest period will be given to patients. Preparatory instructions for the desired movement will be given to patients at the start of procedure. PNF facilitation techniques of RI (Rhythmic initiation) \& repeated contractions will be used in all patterns

PNF techniques

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed cases of stage II \& III adhesive capsulitis
  • Referred by orthopedic physician
  • Duration of stage approximately 1 month
  • Both male and female
  • Age: 40-70 years

You may not qualify if:

  • Recent history of trauma
  • Dislocation or fractures of shoulder
  • History of diabetes and hypertension
  • Congenital shoulder deformity
  • Previous surgery patients
  • Patients with diagnosed cardiovascular disease
  • Patients with malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Eckert AJ, Plaumann M, Pehlke S, Beck C, Muhldorfer S, Weickert U, Laimer M, Pfeifer M, Stechemesser L, Holl R. Idiopathic Frozen Shoulder in Individuals with Diabetes: Association with Metabolic Control, Obesity, Antidiabetic Treatment and Demographic Characteristics in Adults with Type 1 or 2 Diabetes from the DPV Registry. Exp Clin Endocrinol Diabetes. 2022 Jul;130(7):468-474. doi: 10.1055/a-1543-8559. Epub 2021 Aug 23.

    PMID: 34425597BACKGROUND
  • Pandey V, Madi S. Clinical Guidelines in the Management of Frozen Shoulder: An Update! Indian J Orthop. 2021 Feb 1;55(2):299-309. doi: 10.1007/s43465-021-00351-3. eCollection 2021 Apr.

  • Prasanna KJ, Rajeswari R and Sivakuma V. Effectiveness of scapular proprioceptive neuromuscular facilitation (pnf) techniques in adhesive capsulitis of the Shoulder Joint. J Physiother Res 2017; 1: 9.

    RESULT
  • Ebadi S, Forogh B, Fallah E, Babaei Ghazani A. Does ultrasound therapy add to the effects of exercise and mobilization in frozen shoulder? A pilot randomized double-blind clinical trial. J Bodyw Mov Ther. 2017 Oct;21(4):781-787. doi: 10.1016/j.jbmt.2016.11.013. Epub 2016 Nov 27.

  • Mishra N, Mishra A and Charaniya P. Effect of scapular proprioceptive neuromuscular facilitation on pain and disability in patients with adhesive capsulitis. Int J Yoga 2019; 4: 995-1000.

    RESULT
  • Balci NC, Yuruk ZO, Zeybek A, Gulsen M, Tekindal MA. Acute effect of scapular proprioceptive neuromuscular facilitation (PNF) techniques and classic exercises in adhesive capsulitis: a randomized controlled trial. J Phys Ther Sci. 2016 Apr;28(4):1219-27. doi: 10.1589/jpts.28.1219. Epub 2016 Apr 28.

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Muhammad sh butt

    University of Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 4, 2021

First Posted

December 9, 2021

Study Start

December 10, 2021

Primary Completion

January 10, 2022

Study Completion

January 20, 2022

Last Updated

December 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share