NCT06064396

Brief Summary

The aim of this study is to determine the effects of Gong's mobilization with and without Stecco Fascial therapy on pain, range of motion and function in patients with Adhesive capsulitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

First Submitted

Initial submission to the registry

September 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

September 26, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

Adhesive CapsulitisPainRange of Motion

Outcome Measures

Primary Outcomes (6)

  • Pain: Numeric Pain Rating Scale (NPRS)

    Changes from baseline Numeric pain rating scale is The 11-point scale used to capture the patient's level of pain. The scale is anchored on the left with the phrase ''no pain'' and on the right with the phrase ''worst imaginable pain.'' Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. Numeric pain scales have been shown to be reliable and valid with validity range from 0.86 to 0.95 and high test-retest reliability r=0.96

    4th week

  • Range of Motion Shoulder (Flexion)

    Changes from baseline ROM range of motion of shoulder flexion will be taken with the help of universal goniometer.

    4th week

  • Range of Motion Shoulder (Abduction)

    Changes from baseline ROM range of motion of shoulder abduction will be taken with the help of universal goniometer.

    4th week

  • Range of Motion Shoulder (External rotation)

    Changes from baseline ROM range of motion of shoulder external rotation will be taken with the help of universal goniometer.

    4th week

  • Range of Motion Shoulder (Internal rotation)

    Changes from baseline ROM range of motion of shoulder internal rotation will be taken with the help of universal goniometer.

    4th week

  • Function: Shoulder Pain and Disability Index (SPADI) Questionnaire

    Changes from baseline SPADI. SPADI questionnaire is used for the self-assessment of symptoms and function of the shoulder. 13 items (total score): 5 items for pain and 8 for function (sub scores). Response options/scale. All SPADI items are originally scored on a visual analog scale (VAS) from no pain/no difficulty to worst pain imaginable/so difficult required help. The VAS line was divided into 12 equal intervals to obtain a 12-point numerical rating scale (NRS) ranging from 0 (best) to 11 (worst).

    4th week

Study Arms (2)

Gong's Mobilization with Stecco Fascial Therapy

EXPERIMENTAL

Participants in this group will receive Gong's Mobilization with Stecco Fascial Therapy

Other: Gong's MobilizationOther: Stecco Fascial Therapy

Gong's Mobilization

ACTIVE COMPARATOR

Participants in this group will receive Gong's Mobilization

Other: Gong's Mobilization

Interventions

The duration of intervention will be 4 weeks, 3 sessions a week, a total of 12 sessions will be given to the study participants. Each session will last for 30 minutes. Conventional physical therapy will be given to participants along with Gong's Mobilization.

Gong's MobilizationGong's Mobilization with Stecco Fascial Therapy

The duration of intervention will be 4 weeks, 3 sessions a week, a total of 12 sessions will be given to the study participants. Each session will last for 30 minutes. Conventional physical therapy will be given to participants along with stecco fascial therapy.

Gong's Mobilization with Stecco Fascial Therapy

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female patients
  • Patients with positive capsular pattern of glenohumeral joint which is external rotation, abduction and internal rotation
  • Patients aged 35-60 years with shoulder pain and reduction in range of motion
  • Unilateral stage II frozen shoulder with shoulder pain and stiffness for more than 3 months

You may not qualify if:

  • Patients with additional cervical or shoulder pathology
  • Patients with shoulder dislocation, rotator cuff rupture and injury
  • Medical red flag history (tumor, metabolic diseases, rheumatoid arthritis, osteoporosis or Infection)
  • Neurological disorder or symptomatic herniated disc or severe disorders of the cervical spine
  • History of Severe trauma or any fracture or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arif Memorial Teaching Hospital

Lahore, Punjab Province, 54600, Pakistan

Location

Related Publications (8)

  • Neviaser AS, Hannafin JA. Adhesive capsulitis: a review of current treatment. Am J Sports Med. 2010 Nov;38(11):2346-56. doi: 10.1177/0363546509348048. Epub 2010 Jan 28.

    PMID: 20110457BACKGROUND
  • Tasto JP, Elias DW. Adhesive capsulitis. Sports Med Arthrosc Rev. 2007 Dec;15(4):216-21. doi: 10.1097/JSA.0b013e3181595c22.

    PMID: 18004221BACKGROUND
  • Wang K, Ho V, Hunter-Smith DJ, Beh PS, Smith KM, Weber AB. Risk factors in idiopathic adhesive capsulitis: a case control study. J Shoulder Elbow Surg. 2013 Jul;22(7):e24-9. doi: 10.1016/j.jse.2012.10.049. Epub 2013 Jan 24.

    PMID: 23352186BACKGROUND
  • Tighe CB, Oakley WS Jr. The prevalence of a diabetic condition and adhesive capsulitis of the shoulder. South Med J. 2008 Jun;101(6):591-5. doi: 10.1097/SMJ.0b013e3181705d39.

    PMID: 18475240BACKGROUND
  • Wadsworth CT. Frozen shoulder. Phys Ther. 1986 Dec;66(12):1878-83. doi: 10.1093/ptj/66.12.1878.

    PMID: 3786418BACKGROUND
  • Celik D. Comparison of the outcomes of two different exercise programs on frozen shoulder. Acta Orthop Traumatol Turc. 2010;44(4):285-92. doi: 10.3944/AOTT.2010.2367.

    PMID: 21252605BACKGROUND
  • Day JA, Stecco C, Stecco A. Application of Fascial Manipulation technique in chronic shoulder pain--anatomical basis and clinical implications. J Bodyw Mov Ther. 2009 Apr;13(2):128-35. doi: 10.1016/j.jbmt.2008.04.044. Epub 2008 Jun 24.

    PMID: 19329049BACKGROUND
  • Russell S, Jariwala A, Conlon R, Selfe J, Richards J, Walton M. A blinded, randomized, controlled trial assessing conservative management strategies for frozen shoulder. J Shoulder Elbow Surg. 2014 Apr;23(4):500-7. doi: 10.1016/j.jse.2013.12.026.

    PMID: 24630545BACKGROUND

MeSH Terms

Conditions

BursitisPain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rabiya Noor, Phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding,refers to a practice where study participants are prevented from knowing certain information that may somehow influence them-thereby tainting the results.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 3, 2023

Study Start

October 20, 2023

Primary Completion

December 30, 2023

Study Completion

January 25, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations