Application of an Exercise Program Versus Exercise Plus Manual Therapy in the Treatment of Adhesive Capsulitis.

NCT06497348 | Not Yet Recruiting

• 1 other identifier: 10111999
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to evaluate whether a treatment program combining manual therapy (joint mobilization) and exercise is more effective in the treatment of adhesive capsulitis than an exercise program applied in isolation. The researchers will compare both groups (experimental group and control group) using the different techniques. During the sessions, mobility will be evaluated with a goniometer and data will be recorded to monitor progress, maintaining a confidential record of the data.

Conditions

Capsulitis of Shoulder; Frozen Shoulder

Keywords

"adhesive capsulitis"; "frozen shoulder"; "manual therapy"; "therapeutic exercise"

Outcome Measures

Primary Outcomes (1)

• evaluation of the improvement of shoulder mobility in patients with adhesive capsulitis by performing by an exercise program, mobilization or boths techniques.

  study and measure if there is improvement in adhesive capsulitis of the shoulder with the proposed exercise programs versus exercise plus manual therapy in 108 subjects, 54 subjects in each group and a descriptive analysis of the data will be carried out, examining the initial homogeneity between the groups. in terms of the variables age, sex, pain, range of motion and functionality. The Shoulder Pain and Disability Index (SPADI) questionnaire and the visual analogue scale (VAS) will be used to assess pain.

  3-4 months

Study Arms (2)

experimental group

EXPERIMENTAL

The experimental group will receive mobilization treatment and exercises, while the control group will receive only exercises. Weekly one-hour sessions will be held, from Monday to Friday, with two times available for each patient. Changes in pain, mobility and functionality will be recorded in an Excel document to monitor progress. To the experimental group, treated by physiotherapists who know the pathology, Maitland mobilization techniques will be applied, focused on passive neural and joint mobilizations. Flexion-extension, abduction-adduction, and external and internal rotation movements will be performed.

Other: manual therapy and exercises (experimental group) or only exercises (control group) in people with frozen shoulder

control group

ACTIVE COMPARATOR

The control group, treated by physiotherapists who will blindly evaluate the patients, will only be prescribed exercises, the same as the experimental group.

Other: manual therapy and exercises (experimental group) or only exercises (control group) in people with frozen shoulder

Interventions

manual therapy and exercises (experimental group) or only exercises (control group) in people with frozen shoulder OTHER

They will be divided into two groups, one experimental (they will be mobilized and given exercises to see whether or not they gain joint range in the different movements of flexion-extension, abduction-adduction and internal rotation-external rotation) and another control group ( The patients will be blindly evaluated and they will be given the same exercises as the experimental group)

control group; experimental group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• men and women from 40 to 60 years old, whether or not they carry out physical activity
• intervention through therapeutic exercise and/or joint mobility.

You may not qualify if:

• children
• older people
• people with previous shoulder pathology
• people with cognitive impairment who cannot complete questionnaires
• treatment that does not include exercise or joint mobility
• treatment with machines.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Facultad de Enfermeria y Fisioterapia de la Universidad de Alcalá de Henares

Madrid, 28801, Spain

Location

MeSH Terms

Conditions

Bursitis

Interventions

Musculoskeletal Manipulations; Exercise; Control Groups

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Cecilia Sánchez Pérez

CONTACT

655515548; cecilia.sanchezperez@edu.uah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator of the study Application of an exercise program versus exercise plus manual therapy in the treatment of adhesive capsulitis.

Model Details: The evaluation of each group will be carried out in different rooms of the university, a team of 6 physiotherapists divided into two groups, where 3 will evaluate with knowledge of the pathology and the other 3 without knowledge of it. The experimental group will receive mobilization treatment and exercises, while the control group will receive only exercises. Weekly one-hour sessions will be held, from Monday to Friday, with two times available for each patient. The experimental group, treated by physiotherapists who know the pathology, will be applied Maitland mobilization techniques, focused on passive neural and joint mobilizations. Flexion-extension, abduction-adduction, and external and internal rotation movements will be performed. The control group, treated by physiotherapists who will blindly evaluate the patients, will only be prescribed exercises, the same as the experimental group.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 11, 2024
• Study Start: July 15, 2024
• Primary Completion: November 10, 2024
• Study Completion: December 15, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)