NCT05785104

Brief Summary

The aim of the study is to determine the effect of muscle energy technique versus myofascial release on cervical and lumbar pain in premenopausal women with fibromyalgia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

March 14, 2023

Last Update Submit

March 5, 2024

Conditions

Keywords

Cervical pain,lumbar pain,fibromyalgia

Outcome Measures

Primary Outcomes (3)

  • Fibromyalgia impact questionnaire

    Used to assess health related quality of life before and after the treatment, maximum score means worse outcome

    Four weeks

  • Visual analogue scale

    Used to assess the severity of cervical and lumbar pain of each premenopausal women in both groups before and after the treatment, maximum score means worse outcome

    Four weeks

  • Active range of motion of cervical and lumbar regions

    Measurement of active flexion, extension, lateral flexion in cervical and lumbar regions before and after the treatment

    Four weeks

Study Arms (2)

Myofascial release

EXPERIMENTAL

The patients will receive myofascial release technique on cervical and lumbar regions three times per week for four weeks

Other: Myofascial release

Muscle energy technique

EXPERIMENTAL

The patients will receive muscle energy technique for cervical and lumbar regions three times per week for four weeks

Other: Muscle energy technique

Interventions

Is Facilitation of mechanical and neurological adaptive capacity as integrated through the Myofascial system

Myofascial release

Is manual therapy procedure that involves alternating periods of resisted muscle contraction and assisted stretching

Muscle energy technique

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal women with fibromyalgia
  • Ages ranges between 30 - 45 years old
  • Body mass index \< 35 kg/m2
  • All are medically stable

You may not qualify if:

  • specific cervical and lumbar pain
  • Smokers
  • Pregnant women
  • Medically unstable
  • Postmenopausal women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Somatoform DisordersNeck Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Mental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups, one group will be treated by muscle energy technique and other will be treated by myofascial release
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Samar Ahmed Abd El Salam Negm

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 27, 2023

Study Start

May 1, 2023

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Locations