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

NCT ID: NCT06449261

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-22
• Study Completion Date: 2025-02-28

Brief 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.

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..

Conditions

Adhesive Capsulitis of Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Spinal Manual therapy used in Physiotherapy Practice

Intervention Type: OTHER

C5-C6 and thoracic spine mobilization with postural correction

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.

Group Type: ACTIVE_COMPARATOR

Spinal Manual therapy used in Physiotherapy Practice

Intervention Type: OTHER

C5-C6 and thoracic spine mobilization with postural correction

Interventions

Spinal Manual therapy used in Physiotherapy Practice

C5-C6 and thoracic spine mobilization with postural correction

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 27 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gulf Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Watson Arulsingh D R, PhD

Role: PRINCIPAL_INVESTIGATOR

Gulf Medical University

Locations

Sharad

Al Jurf, Ajman, United Arab Emirates

Site Status: RECRUITING

Thumbay Hospital

Ajman, , United Arab Emirates

Site Status: RECRUITING

Countries

United Arab Emirates

Central Contacts

Watson Arulsingh D R, PhD

Role: CONTACT

dr.watson@gmu.ac.ae

+971505708763

Rania Zaarour

Role: CONTACT

dr.rania@gmu.ac.ae

+971 6 7431333

Facility Contacts

Watson Arulsingh, PhD

Role: primary

Praveen Kumar KANDAKURTI, PhD

Role: primary

dean.coahs@gmu.ac.ae

(+971 6) 7431333 ext. 1386

Other Identifiers

IRB-COHS-FAC-134-MAY-2024

Identifier Type: -

Identifier Source: org_study_id