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

Adhesive Capsulitis of Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06449261
• Other study ID #: IRB-COHS-FAC-134-MAY-2024
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Gulf Medical University
• Contact: Watson Arulsingh D R, PhD
• Phone: +971505708763
• Email: dr.watson[@]gmu.ac.ae
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: February 28, 2025
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 27 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis of Shoulder
• Bursitis

Intervention

Other:
• Spinal Manual therapy used in Physiotherapy Practice
C5-C6 and thoracic spine mobilization with postural correction

Locations

Country	Name	City	State
United Arab Emirates	Thumbay Hospital	Ajman
United Arab Emirates	Sharad	Al Jurf	Ajman

Sponsors (1)

Lead Sponsor	Collaborator
Gulf Medical University

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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