Thoracic Mobility in Cystic Fibrosis Care

Göteborg University

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Other: Standard care; Other: Manual Therapy Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04696198

FoU i VGR: 272 800

Details and patient eligibility

About

Cystic fibrosis (CF) is an inherited, genetic disease of the body's mucus-producing glands that primarily affects the lungs and gastrointestinal tract. There are no studies that have examined anatomical changes, the connection between structure and function in the ribcage and the effect of symptom-relieving manual treatment.

The purpose of the study is therefore to investigate chest mobility in people with CF.

Method The study is conducted in three parts; a / A retrospective longitudinal part whose purpose is to investigate possible changes in the chest configuration in relation to deterioration of lung volumes in a cohort of CF patients. Chest configuration will be measured standardized and blinded on computed tomography (CT) images and related to results from spirometry examinations.

b / A prospective, consecutive cross-sectional study of the same cohort. The aim is to investigate the extent of stiffness and pain that is examined standardized (number of pain-free / normal moving structures) and its relation to objective examination of respiratory movements, respiratory muscle strength and spirometry.

c / A randomized controlled single-blind study aimed at evaluating the effect of manual treatment for pain and reduced mobility in patients with these symptoms. The treatments consist of standardized manual therapy with passive joint mobilization without impulse and soft tissue treatment. Evaluation will be done via the examination protocol in sub-study b / as well as objective measurements of respiratory movements (primary variable), respiratory muscle strength and spirometry which will be performed by a blinded tester both before and immediately after the intervention / control period.

Clinical significance When it comes to CF care, great medical advances have been made and for Swedish patients, the physiotherapeutic active treatment has proven to have very good effects. However, there are areas where care can be improved. The results from our study will provide additional breadth to strategies in CF care

Enrollment: 63 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with cystic fibrosis
• >18 years of age

Exclusion criteria

• participation in clinical trials or other interventional studies, or, medical conditions that -as judged by the medical doctor in charge contraindicates the proposed intervention.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups

Range of motion

Experimental group

Description:

Treatment is based on a set diagnostic and therapeutic protocol and carried out by registered health care professionals that are additionally trained in manual therapy intervention. 30 minutes of treatment will be given once a week over a period of two months

Treatment:

Other: Manual Therapy Intervention

Standard care

Other group

Description:

Standard care

Treatment:

Other: Standard care