NCT07791134

Brief Summary

The aim of this randomized controlled study is to investigate the immediate effect of connective tissue massage (CTM) on the pressure pain threshold (PPT) in women with fibromyalgia.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

August 25, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

August 25, 2026

Last Update Submit

August 25, 2026

Conditions

FibromyalgiaPRESSURE PAIN THRESHOLD

Outcome Measures

Primary Outcomes (1)

  • Measurement of pressure pain threshold

    PPT will be determined using a handheld digital algometer with a 1 cm² probe. Measurements will be taken bilaterally at three points: the trapezius, lumbar region, and pretibial area. In the control group, the first measurement will be taken, followed by a second measurement approximately 20 minutes later. In the CTM group, measurements will be taken before and after the CTM procedure.

    Baseline and 20 minutes post-intervention

Study Arms (2)

Control Group

NO INTERVENTION

CTM Group

EXPERIMENTAL
Other: Connective Tissue Massage

Interventions

Connective Tissue MassageOTHER

Single-session CTM application for the entire back

CTM Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a diagnosis of FM
  • Being a woman between the ages of 18 and 65
  • Being willing to participate in the study

You may not qualify if:

  • Diagnosed additional neurological, infectious, and other inflammatory rheumatic diseases; uncontrolled endocrine and/or autoimmune diseases
  • Severe psychiatric disorders
  • Pregnancy or breastfeeding
  • Malignancy
  • Presence of acute inflammation, open wounds, or erythema in the massage areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

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
PhD Candidate

Study Record Dates

First Submitted

August 25, 2026

First Posted

August 27, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

August 27, 2026

Record last verified: 2026-08