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What Concept of Manual Therapy is More Effective?

E

European University

Status

Completed

Conditions

Kinesiophobia
Self Efficacy
Quality of Life
Depression
Catastrophizing
Anxiety
Sleep
Central Sensitisation

Treatments

Other: Myofascial Therapy Treatments
Other: Passive Mobilizations Approach

Study type

Interventional

Funder types

Other

Identifiers

NCT05559021
Concept of Manual Therapy

Details and patient eligibility

About

The aim of the study will be to find out which manual therapy approach is most effective for the improvement of symptoms (sensory, cognitive, emotional and social) in people with Fibromyalgia.

Full description

A randomized clinical trial will be conducted in 52 patients with Fibromyalgia who will undergo a myofascial treatment approach or a passive mobilization treatment approach. Data will be collected on the improvement of symptom severity, quality of life, self-efficacy, kinesiophobia, catastrophizing, central sensitization, anxiety, depression, and sleep. After the treatments, follow-ups will be made, and the results are expected to be disseminated to the scientific community during and after the end of the study.

Enrollment

52 patients

Sex

Female

Ages

18 to 62 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Less than 62 years old
  • Medical Diagnosis of Fibromyalgia
  • The individuals included in the study had a minimum one-year history of symptoms
  • To confirm the medical diagnosis of fibromyalgia, the physical therapists and study investigators used the 2010 American College of Rheumatology (ACR) diagnostic criteria. -Since 2 of the measurement variables used in the study (WPI and SS-Score) match the protocol when determining these criteria, this procedure was facilitated.

The diagnostic criteria establish the diagnosis of fibromyalgia when12 : IDG/WPI ≥ 7 and SS ≥ 5 or IDG/WPI 4-6 and SS ≥ 9.

Exclusion criteria

  • Intolerance to touch
  • A change of medication in the last 2-3 months
  • Agree not to change their medication during the study

Exclusion Criteria:

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Myofascial Treatment Approach
Experimental group
Description:
Patients will have 1 session per week, during 4 weeks, making 4 sessions in total. Each session will last 30 minutes. Each session consists of: * Transverse planes in the thoracolumbar fascia and abdomen: The physical therapist place his hands facing each other so that one hand is between the tables and the patient's thoracolumbar fascia and the other on the abdomen * Transverse planes at C7-D3 and sternum: The physical therapist, places one hand between the table and the patient's first 4 thoracic vertebrae (C7-T4) and the other on the sternum. * Suboccipital inhibition: the physical therapist, places his hands under the patient's head transversely between the occipital and the spinous process of C2. After, the head is lowered in such a way that the occipital bone rests on the tenar eminences and a slight traction is maintained cranially.
Treatment:
Other: Myofascial Therapy Treatments
Mobilization Approach.
Experimental group
Description:
Patients will have 1 session per week, for 4 weeks, which means 4 sessions in total. Each session will last 30 minutes. Each session consists of: * Postero-anterior cervical sliding: the patient's cervical vertebrae will be evaluated with the 4 degrees of postero-anterior sliding, and the pain at each vertebral level is recorded. Then, the most painful vertebra previously detected will be treated. * Postero-anterior lumbar slippage: the patient's lumbar vertebrae will be evaluated with the 4 degrees of postero-anterior slippage, and the pain at each vertebral level is recorded. Afterwards, the most painful vertebra previously detected will be treated. * Postero-anterior dorsal slippage: the patient's dorsal vertebrae will be evaluated with the 4 degrees of postero-anterior slippage, and the pain at each vertebral level is recorded. Then, Afterwards, it will treat during the most painful vertebra previously detected.
Treatment:
Other: Passive Mobilizations Approach

Trial contacts and locations

2

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Central trial contact

Eleuterio A. Sánchez Romero, PhD

Data sourced from clinicaltrials.gov

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