Efficacy of Manual Therapy and Exercise in Patients With Shoulder Adhesive Capsulitis. A Randomized Clinical Trial.

NCT02976974 | Unknown

• 1 other identifier: UMA MTEAC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

The efficacy of manual therapy and therapeutic exercise in patients suffering from adhesive capsulitis of the shoulder will be studied. Furthermore, different biomechanic and psychosocial factors will be measured with a nine month follow-up

Conditions

Shoulder Pain

Keywords

chronic pain; central sensitization; function; force; ultrasonography

Outcome Measures

Primary Outcomes (1)

• Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at nine months

  The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.

  time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)

Secondary Outcomes (14)

• Change from baseline pressure algometry at nine months

  time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)

• Change from baseline ultrasonography at nine months

  time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)

• Change from baseline electromyography at nine months

  time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)

• Change from baseline dynamometry at nine months

  time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)

• Change from baseline blood glucose concentration at nine months

  time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)

Study Arms (2)

Manual therapy (MT)

EXPERIMENTAL

MT: Manual Therapy. Application of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done.

Other: Manual therapy

Therapeutic exercise (E)

EXPERIMENTAL

E: Therapeutic Exercise. Shoulder extension: Elastic bands. Shoulder flexion: Elastic bands Shoulder external rotation: Elastic bands. Scapulothoracic stability: Movement of scapular adduction guided by the physiotherapist, keeping the position for few seconds ; standing "push up" on the wall. Thoracic column movements: Flexion-extension

Other: Manual therapy; Other: Therapeutic exercise

Interventions

Manual therapy OTHER

Application of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done.

Manual therapy (MT); Therapeutic exercise (E)

Therapeutic exercise OTHER

* Shoulder extension: Elastic bands. * Shoulder flexion: Elastic bands * Shoulder external rotation: Elastic bands. * Scapulothoracic stability: Movement of scapular adduction guided by the physiotherapist, keeping the position for few seconds ; standing "push up" on the wall. * Thoracic column movements: Flexion-extension

Therapeutic exercise (E)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• People suffering from adhesive capsulitis as indicated by passive range of motion loss \>25% in at least 2 movement planes, together with at least 50% loss of passive external rotation in comparison with the uninvolved shoulder.

You may not qualify if:

• Shoulder pain that was deemed to be originating from any passive and/or neck movement or if there was a neurological impairment, osteoporosis, haemophilia and/or malignancies
• Corticoid injections during the six months prior to the study
• Analgesic-antiinflammatory medication intake during the intervention phase of the study.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (3)

Las Albarizas primary care centre

Fuengirola, Malaga, 29603, Spain

RECRUITING

Las Lagunas Care Centre

Fuengirola, Malaga, 29651, Spain

RECRUITING

San Pedro primary care centre

Marbella, Malaga, 29670, Spain

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Chronic Pain

Interventions

Musculoskeletal Manipulations; Exercise Therapy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• ALEJANDRO LUQUE-SUAREZ, PT, PhD

  UNIVERSITY OF MALAGA, SPAIN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ANTONIO RONDON-RAMOS, PT

CONTACT

0034 610566313; antonio.rondon.sspa@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Efficacy of manual therapy and exercise in patients with shoulder adhesive capsulitis. Which biomechanics/psychological factors are more correlated with?

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 30, 2016
• Study Start: July 30, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 1, 2020
• Last Updated: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

ES (3)