Manual Therapy of Spine With Postural Correction Exercise Compared With Conventional Therapy in Patients With Adhesive Capsulitis - A Randomised Clinical Trial

C5-C6 and Thoracic Spine Mobilization With Postural Correction Exercise Compared With Conventional Therapy in Patients With Adhesive Capsulitis - A Two-group, Parallel-arm, Single-blinded, Randomized Clinical Trial

Adhesive capsulitis (AC) is often self-limited but can persist for years and may never fully resolve. The most effective treatment for adhesive capsulitis is uncertain till date. Though neural links are being studied on one side and postural alteration too was postulated to cause shoulder pathology. However, the effectiveness of C5-C6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of AC. This study aimed to investigate whether C5-C6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(ROM), and disability in patients with AC. The outcome of the study must provide valid information to enhance the prognostic value of adhesive capsulitis.

Study Overview

• Status: Recruiting
• Conditions: Adhesive Capsulitis of Shoulder
• Intervention / Treatment: Other: Spinal Manual therapy used in Physiotherapy Practice

Detailed Description

Adhesive capsulitis (AC) is often self-limited but can persist for years and may never fully resolve. The most effective treatment for adhesive capsulitis is uncertain till date. Though neurological control of the shoulder girdle muscles is mainly from cervical roots, particularly from C5/C6 roots, there was not sufficient research to associate this link with AC. Evidence confirms that there is an association between posture and shoulder mobility. However, the effectiveness of C5-C6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of AC. We aimed to investigate whether C5-C6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(ROM), and disability in patients with AC.

Methods The protocol is written according to the SPIRIT statement to enhance transparency of content and completeness. Two-group, randomized controlled trial with blinded assessors. A total of 66 adults with AC will be randomly assigned to experimental group to receive C5-C6 and thoracic spine mobilization with postural correction sessions (n=33) and the others(n=33) in control group to receive conventional therapy within a period of 3 weeks. Primary outcomes are Shoulder Pain, range of motion (ROM) of the shoulder joint and Disability Index (SPADI) were to be measured at pre, postintervention following 3 weeks and 3 months..

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Watson Arulsingh D R, PhD; Phone Number: +971505708763; Email: dr.watson@gmu.ac.ae
• Study Contact Backup: Name: Rania Zaarour; Phone Number: +971 6 7431333; Email: dr.rania@gmu.ac.ae

Study Locations

• United Arab Emirates
  • Ajman, United Arab Emirates, 4184
    • Recruiting
    • Thumbay Hospital
    • Contact: Praveen Kumar KANDAKURTI, PhD; Phone Number: 1386 (+971 6) 7431333; Email: dean.coahs@gmu.ac.ae
  • Ajman
    • Al Jurf, Ajman, United Arab Emirates
      • Recruiting
      • Sharad
      • Contact: Watson Arulsingh, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with AC & a Positive for Apley's scratch test.
• Adhesive capsulitis (with symptoms for at least three months and less than 12 months[18]
• Both Gender
• Age 27-70
• Sleep-disturbing night pain

Exclusion Criteria:

• Patients who are unwilling to participate
• patients with malignancy
• AC Secondary to fracture and uncontrolled hypertension.
• Unstable cardiac conditions
• Patient with neurological conditions
• Patient with reported concurrent cervical issues

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group receives C5-C6 and thoracic spine mobilization with postural correction; The patient will be made to lie in a prone position with the therapist beside her/his height- adjusted couch. Then the therapist who is certified to provide manual therapy will impart grade III+ posterior-to-anterior mobilization/lateral glide according to Maitland class cation focused on the cervical spine, C5-6 segment for 3 bouts of 30 seconds/2 days in a week for 3 weeks. Followed by the patient will be permitted to rest for a few minutes less than 10 minutes before starting the thoracic mobilisation. Thoracic mobilisation will be administered both at central and unilateral postero-anterior passive accessory intervertebral motions (PAIVMs) based on manual therapy evaluation at the thoracic spine.	Other: Spinal Manual therapy used in Physiotherapy Practice; C5-C6 and thoracic spine mobilization with postural correction
Active Comparator: Group receives conventional therapy; Controls will receive ultrasound therapy, passive shoulder mobilisation focussed at Glenohumeral joint, self-stretching exercises and patient education by qualified therapist according to clinical practice guidelines while the experimental group underwent spine mobilization with postural correction exercises for 3 weeks.	Other: Spinal Manual therapy used in Physiotherapy Practice; C5-C6 and thoracic spine mobilization with postural correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion of shoulder	The smartphone clinometer (Plaincode Software Solutions) is readily available at low cost for several smartphones, including the iPhone, which will be used by all examiners in this study	1 Year
SPADY scale	In the original version, the patient was instructed to place a mark on the VAS for each item that best represented their experience of their shoulder problem over the last week [26]. Each subscale is summed and transformed to a score out of 100. A mean is taken of the two subscales to give a total score out of 100, a higher score indicating greater impairment or disability.	1 Year
Cervical Range of motion	Clinometer app on smartphones is a reliable and valid device for assessing cervical flexion, extension, lateral flexion, and rotation. The results from the study demonstrated moderate to excellent (ICC = .87-.96) concurrent validity in all 6 cervical movements when compared with the universal goniometric measurements	1 Year

Collaborators and Investigators

• Sponsor: Gulf Medical University
• Investigators: Principal Investigator: Watson Arulsingh D R, PhD, Gulf Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2024
• Primary Completion (Actual): May 20, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: May 11, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: IRB-COHS-FAC-134-MAY-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No