What Concept of Manual Therapy is More Effective?

NCT05559021 | Completed

• 1 other identifier: Concept of Manual Therapy
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Manual Therapy; Chronic Pain; Fibromyalgia; Passive Mobilizations; Myofascial Approach; Symptom Severity

Outcome Measures

Primary Outcomes (3)

• Pain Expansion

  This will be classified as a continuous numerical variable measured by the Widespread Pain Index (WPI). In this index, the patient has to mark with an x the areas in which he/she has presented pain during the last week

  Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention

• Symptom severity

  This variable will be classified as a continuous numerical variable, measured by the Symptom Severity Index (SSI/SS-Score), composed of two subscales (SS-1 and SS-2) that assess the intensity during the last week of 3 of the main symptoms present in FM (fatigue, unrefreshing sleep and cognitive disorders), as well as the presence/absence of other common symptoms, respectively. The total score of the SSS is the sum total and ranges from 0 to 12. The SSS correlated correlates strongly with the WPI (r=0.733) and with the presence of Tender Points (r=0.680)

  Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention

• Fibromyalgia Impact Questionnaire

  Another measurement variable will be the impact of fibromyalgia on quality of life, through the Fibromyalgia Impact Questionnaire (FIQ), a tool translated into Spanish by means of the international translation-retrotranslation recommendations, and whose reliability, validity, adaptation and sensitivity to change have been satisfactorily analyzed in Spanish patients with fibromyalgia. Consists of 19 items that measure three main categories (a) "function" - ten items that as-sess the participant's physical functions that address the participant's ability to perform each activity. This domain is assessed on a 4-point Likert scale, from 0 to 3 (0= always, 1= always, 1= always, 2= always, 3= always). 0 to 3 (0= always, 1= frequently, 2= occasional-ly, 3= never). (b) "Global impact" - composed of two items assessing the number of days in the last week when the participants felt good and the number of days they could not work due to FM symptoms

  Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention

Secondary Outcomes (7)

• kinesiophobia

  Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention

• Self-Efficacy

  Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention

• Anxiety

  Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention

• Depression

  Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention

• Quality of life (EQ-5D-5L)

  Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention

Study Arms (2)

Myofascial Treatment Approach

EXPERIMENTAL

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.

Other: Myofascial Therapy Treatments

Mobilization Approach.

EXPERIMENTAL

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.

Other: Passive Mobilizations Approach

Interventions

Myofascial Therapy Treatments 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

Myofascial Treatment Approach

Passive Mobilizations Approach 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

Mobilization Approach.

Eligibility Criteria

• Age: 18 Years - 62 Years
• Gender Eligibility Details: An experimental study will be conducted at the Fibromyalgia and Chronic Fatigue Association of Móstoles, Madrid, Spain. This is an all-female center. However, the prevalence of fibromyalgia is much higher in women (5:1 ratio, with respect to men), so the next study is highly relevant.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (2)

Eleuterio A. Sánchez Romero

Madrid, 28670, Spain

Location

Universidad Europea de Madrid

Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Kinesiophobia; Anxiety Disorders; Depression; Chronic Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Phobic Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Eleuterio A. Sánchez Romero, PhD

  European University of Madrid

  PRINCIPAL INVESTIGATOR

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

Model Details: A randomized clinical trial will be conducted between October 2022 and December 2023 in 52 female patients impacted by Fibromyalgia who will undergo a myofascial treatment approach or mobilization treatment approach , with 3 months of follow-up post-treatment.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 29, 2022
• Study Start: October 20, 2022
• Primary Completion: September 15, 2023
• Study Completion: December 15, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)