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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frozen Shoulder; Capsulitis of Shoulder
• Intervention / Treatment: Other: manual therapy and exercises (experimental group) or only exercises (control group) in people with frozen shoulder

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecilia Sánchez Pérez; Phone Number: 655515548; Email: cecilia.sanchezperez@edu.uah.es

Study Locations

• Spain
  • Madrid, Spain, 28801
    • Facultad de Enfermeria y Fisioterapia de la Universidad de Alcalá de Henares

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; 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; 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)
Active Comparator: control group; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Alcala

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2024
• Primary Completion (Estimated): November 10, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: "adhesive capsulitis"; "frozen shoulder"; "manual therapy"; "therapeutic exercise"
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: 10111999

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD, since patient data will be recorded along with informed consent, to which only patients and researchers will have access.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No