NCT05347355

Brief Summary

Adhesive capsulitis can be defined as insidious and progressive loss of both active and passive shoulder mobility in the glenohumeral joint presumably due to capsular contracture. It is associated with inflammation and stiffness of the capsule surrounding the glenohumeral joint, greatly restricting motion and causing chronic pain. The objective of this study is to compare the effects of spencer technique and gongs mobilization on pain, range of motion, disability, and scapular symmetry in patients with phase II adhesive capsulitis. This study will be a Randomized Clinical trial involving 48 patients both males and females aged 40 to 60 years clinically diagnosed cases of phase II adhesive capsulitis. Patients will be randomly assigned into two groups using consecutive sampling technique. Group A will be treated with conventional treatment and spencer technique whereas Group B will be treated with conventional treatment and gongs mobilization. Numeric Pain Rating Scale will be used to measure pain of patients. Shoulder Pain and Disability Index score will be used to ask some questions related to patient's symptoms and disability. Lateral scapular slide test will be used to measure scapular symmetry and universal goniometer will be used to measure range of motion of shoulder joint. Each session will be repeated for 40 minutes thrice a week. All participants of the study will fill the Numeric Pain Rating Scale and Shoulder Pain and Disability Index score on day 1 as pretreatment values and at the end of 4th week as post treatment values respectively. The collected data will be analyzed on SPSS - 25. Key words: Adhesive, scapula, mobilizations, glenohumeral joint, pain

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

April 21, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

8 months

First QC Date

April 21, 2022

Last Update Submit

June 15, 2022

Conditions

Keywords

Adhesivescapulamobilizationglenohumeral joint

Outcome Measures

Primary Outcomes (4)

  • NUMERIC PAIN RATING SCALE

    Numeric pain rating scale is a measurement of pain intensity in adults. The NPRS is a segmented numeric version of visual analogue scale (VAS) in which respondent select a whole number (0 to 10) that best reflects the intensity of pain. Scores range from 0 to 10

    4 weeks

  • SHOULDER PAIN AND DISABILITY INDEX (SPADI)

    SPADI 5 is a self-administered, shoulder-specific, fixed object index composed of 13 items divided into two subscales: pain (five items) and impairment (eight items). Responses to each item were recorded on a 10 point Likert scale, where 0= no pain or no difficulty and 10 =worst imaginable pain or so difficult it required help for the pain and disability items, respectively. The SPADI score is calculated by summing and then averaging the items of the two subscales to give a score out of 100 (higher scores reflects more pain/disability). The SPADI has acceptable test-retest reliability (intraclass correlation coefficients of 0.91 and 0.65 (95% CI, 0.42 to 0.8) in surgical and primary care populations respectively) and acceptable responsiveness

    4 weeks

  • LATERAL SCAPULAR SLIDE TEST

    Three positions are measured with the LSST designed by Kibler, is used to assess the scapular asymmetry under varying loads. To maintain a consistent posture during the various test positions, participants are instructed to fix their eyes on an object in the examination area. First test position, the participant is instructed to keep the arms relaxed at his/her sides, the most inferior aspect of the inferior angle of the scapula and the closest spinous process in the same horizontal plane is identified through palpation and marked. The distance between the 2 reference points is measured bilaterally with the help of a tape measure. This procedure is repeated for test position 2 (participant actively placed both hands on the ipsilateral hips, and consequently the humerus is positioned in medial rotation at -45° of abduction in the coronal plane) and test position 3 (the participant is instructed to maintain thumbs down position

    4 weeks

  • UNIVERSAL GONIOMETER

    Active and passive abduction (in the frontal plane) and external rotation (with the arm at 0 degrees of abduction) ROM measured with a conventional goniometer as per the guidelines given by the American Academy of Orthopedic Surgeons. Goniometric measurements are highly reliable provided measurements are conducted by same therapist (test-retest reliability: 0.94-0.98)

    4 weeks

Study Arms (2)

Spencer technique along with conventional treatment

EXPERIMENTAL
Other: Spencer technique along with conventional treatment

Gongs Mobilization along with conventional treatment

EXPERIMENTAL
Other: Gongs Mobilization along with conventional treatment

Interventions

Subjects in this group will receive conventional exercises and 7 stages of Spencer technique: (A) extension, (B) flexion, (C) circumduction with compression, (D) circumduction with traction, (E) abduction, (F) internal rotation, (G) lymphatic pump. Spencer technique will be used to increase range of motion of the glenohumeral joint. The patient will be positioned lying on the side with the affected shoulder above. The therapist will stabilize the shoulder girdle with the proximal hand and the distal hand will provide force into the restrictive barrier of shoulder in 7 different movements. These will be shoulder extension, circumduction with distraction, abduction, adduction with internal rotation and glenohumeral pump. During all the movements, patient will be asked to use muscle energy against the slight resistance offered by the therapist for 3-5 seconds. The exercise will be repeated 3-5 times with rest intervals over 3 sessions per week on alternate days for 4 weeks.

Spencer technique along with conventional treatment

The Gong's mobilization can be done either in high sitting or in side-lying position with the affected shoulder upward. The subject's shoulder will be abducted at 90° so that the humerus will be maintained at vertical position. The elbow joint will be flexed and maintained at 90°; the therapist will maintain this position by placing his/her hand below the subject's elbow. The humeral head will be pressed from anterior to posterior direction with the other hand. The therapist will hold the vertical axis of the humerus by maintaining the shoulder in abduction and the elbow in 90°. The therapist will raise his own body by slightly pulling on the anterior capsule and this pull will be maintained for 10-15 seconds and then relax for five seconds and will be performed for about two to three minutes. At this moment the subject will be asked to perform shoulder abduction with no external rotation, while elbow flexion will be maintained throughout.

Gongs Mobilization along with conventional treatment

Eligibility Criteria

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

You may qualify if:

  • Patients of age group between 40-60 years.
  • Both Males and Females.
  • Clinically diagnosed patients of phase II adhesive capsulitis will be included.
  • Adhesive Capsulitis subjects with limited Range of motion of shoulder abduction and external rotation.
  • Subjects with bilateral/unilateral adhesive capsulitis.

You may not qualify if:

  • Recent history of surgery on particular shoulder.
  • Patients with rotator cuff tears.
  • Rheumatoid and gouty arthritis.
  • Tumors of the shoulder region.
  • Subjects with acute inflammation.
  • Recent shoulder dislocation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Riphah Rehabilitation Center

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

DHQ Hospital

Sheikhupura, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (4)

  • Iqbal M, Riaz H, Ghous M, Masood K. Comparison of Spencer muscle energy technique and Passive stretching in adhesive capsulitis: A single blind randomized control trial. J Pak Med Assoc. 2020 Dec;70(12(A)):2113-2118. doi: 10.5455/JPMA.23971.

    PMID: 33475581BACKGROUND
  • Nakandala P, Nanayakkara I, Wadugodapitiya S, Gawarammana I. The efficacy of physiotherapy interventions in the treatment of adhesive capsulitis: A systematic review. J Back Musculoskelet Rehabil. 2021;34(2):195-205. doi: 10.3233/BMR-200186.

    PMID: 33185587BACKGROUND
  • Gutierrez Espinoza HJ, Pavez F, Guajardo C, Acosta M. Glenohumeral posterior mobilization versus conventional physiotherapy for primary adhesive capsulitis: a randomized clinical trial. Medwave. 2015 Sep 22;15(8):e6267. doi: 10.5867/medwave.2015.08.6267. English, Spanish.

    PMID: 26485477BACKGROUND
  • Agarwal S, Raza S, Moiz JA, Anwer S, Alghadir AH. Effects of two different mobilization techniques on pain, range of motion and functional disability in patients with adhesive capsulitis: a comparative study. J Phys Ther Sci. 2016 Dec;28(12):3342-3349. doi: 10.1589/jpts.28.3342. Epub 2016 Dec 27.

    PMID: 28174448BACKGROUND

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Saima Zahid, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saima Zahid, PhD*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 26, 2022

Study Start

April 25, 2022

Primary Completion

December 25, 2022

Study Completion

January 10, 2023

Last Updated

June 16, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations