What Concept of Manual Therapy is More Effective?

NCT ID: NCT05559021

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2023-12-15

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Myofascial Treatment Approach

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.

Group Type: EXPERIMENTAL

Myofascial Therapy Treatments

Intervention Type: OTHER

• Myofascial approach: After the bibliographic review of myofascial therapy treatments in fibromyalgia patients based on the articles by CastroSánchez AM et al., and an expert consensus, the following approach was decided: patients would have 4 sessions in total with 1 session per week of 30 minutes each.

• Transverse planes in the thoracolumbar fascia (TCL) and abdomen: Performing a myofascial induction as described by Pilat.
• Transverse planes at C7-D3 and sternum: Performing a myofascial induction as described by Pilat.
• Suboccipital inhibition: Performing a myofascial induction as described by Pilat

Mobilization Approach.

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.

Group Type: EXPERIMENTAL

Passive Mobilizations Approach

Intervention Type: OTHER

• Approach with passive mobilizations: After the literature review of manual therapy treatments in fibromyalgia patients and a consensus of experts in Manual Therapy with more than 15 years of experience, the following approach was agreed upon by the expert: patients would have 4 sessions in total with 1 session per week of 30 minutes each.

• Postero-anterior cervical sliding
• Postero-anterior lumbar slippage
• Postero anterior dorsal slippage

Interventions

Myofascial Therapy Treatments

• Myofascial approach: After the bibliographic review of myofascial therapy treatments in fibromyalgia patients based on the articles by CastroSánchez AM et al., and an expert consensus, the following approach was decided: patients would have 4 sessions in total with 1 session per week of 30 minutes each.

• Transverse planes in the thoracolumbar fascia (TCL) and abdomen: Performing a myofascial induction as described by Pilat.
• Transverse planes at C7-D3 and sternum: Performing a myofascial induction as described by Pilat.
• Suboccipital inhibition: Performing a myofascial induction as described by Pilat

Intervention Type: OTHER

Passive Mobilizations Approach

• Approach with passive mobilizations: After the literature review of manual therapy treatments in fibromyalgia patients and a consensus of experts in Manual Therapy with more than 15 years of experience, the following approach was agreed upon by the expert: patients would have 4 sessions in total with 1 session per week of 30 minutes each.

• Postero-anterior cervical sliding
• Postero-anterior lumbar slippage
• Postero anterior dorsal slippage

Intervention Type: OTHER

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad Europea de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Eleuterio Atanasio Sánchez Romero

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eleuterio A. Sánchez Romero, PhD

Role: PRINCIPAL_INVESTIGATOR

European University of Madrid

Locations

Eleuterio A. Sánchez Romero

Madrid, , Spain

Universidad Europea de Madrid

Madrid, , Spain

Countries

Spain

Other Identifiers

Concept of Manual Therapy

Identifier Type: -

Identifier Source: org_study_id