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

NCT06449261 | Recruiting

• 1 other identifier: IRB-COHS-FAC-134-MAY-2024
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Adhesive Capsulitis of Shoulder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group receives C5-C6 and thoracic spine mobilization with postural correction

EXPERIMENTAL

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

Group receives conventional therapy

ACTIVE COMPARATOR

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

Interventions

Spinal Manual therapy used in Physiotherapy Practice OTHER

C5-C6 and thoracic spine mobilization with postural correction

Group receives C5-C6 and thoracic spine mobilization with postural correction; Group receives conventional therapy

Eligibility Criteria

• Age: 27 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (2)

Sharad

Al Jurf, Ajman Emirate, United Arab Emirates

RECRUITING

Thumbay Hospital

Ajman, 4184, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Watson Arulsingh D R, PhD

  Gulf Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Watson Arulsingh D R, PhD

CONTACT

+971505708763; dr.watson@gmu.ac.ae

Rania Zaarour

CONTACT

+971 6 7431333; dr.rania@gmu.ac.ae

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

Model Details: A two-group, parallel-arm, single-blinded, randomized clinical trial

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: June 7, 2024
• Study Start: February 22, 2024
• Primary Completion: May 20, 2024
• Study Completion: February 28, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AE (2)