NCT07094997

Brief Summary

The piriformis muscle can be a contributing factor to low back pain (LBP) due to its anatomical proximity to the sciatic nerve and sacroiliac joint. When the piriformis becomes tight or irritated, it may compress or irritate the sciatic nerve-a condition often referred to as piriformis syndrome-leading to pain that radiates from the lower back to the buttock and down the leg. The goal of this clinical trial is to examine the effectiveness of massage therapy in counteracting symptoms of low back pain (LBP) among healthcare workers. The main question it aims to answer is: \- Can massage of the piriformis muscle and related musculature effectively reduce symptoms in individuals experiencing LBP linked to myofascial or neuromuscular dysfunction? Massage therapy targeting the piriformis and associated muscles (e.g., gluteus maximus, medius, and deep hip rotators) can help by:

  • Reducing muscle tension and spasms,
  • Improving local blood circulation,
  • Alleviating pressure on the sciatic nerve,
  • Restoring hip mobility and muscle balance.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 31, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

July 29, 2025

Last Update Submit

February 22, 2026

Conditions

Keywords

Randomiezed controlled trialMassage therapy

Outcome Measures

Primary Outcomes (2)

  • VAS scale

    Visual Analogue Scale (VAS) is a continuous scale consisting of a horizontal line, 100 mm long, anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10). VAS is frequently used to determine the effectiveness of treatment as an outcome measure. Most studies show that VAS is a valid and reliable scale.

    From enrollment to the end of treatment at 2 weeks

  • ODI

    The ODI (Oswestry Disability Index) is a standardized questionnaire used to measure a patient's level of disability due to lower back pain. It assesses how back pain affects a person's ability to manage everyday life.

    From enrollment to the end of treatment at 2 weeks

Secondary Outcomes (2)

  • Thermography

    From enrollment to the end of treatment at 2 weeks

  • Doppler USG

    From enrollment to the end of treatment at 2 weeks

Study Arms (3)

Guideline-Based Massage Therapy + Self-Massage Group (GMT+SM)

EXPERIMENTAL

GMT+SM - Massage protocol based on guidelines from the Polish Society of Physiotherapy, the Polish Society of Family Medicine, the College of Family Physicians in Poland, and the European Rural and Isolated Practitioners. Delivered by licensed therapists. Self-Massage Training: One in-person instructional session, plus take-home materials (videos and printed instructions).

Other: Guidline-basaed massage therapy

Guideline-Based Massage Therapy (GMT)

EXPERIMENTAL

GMT - Massage protocol based on guidelines from the Polish Society of Physiotherapy, the Polish Society of Family Medicine, the College of Family Physicians in Poland, and the European Rural and Isolated Practitioners. Delivered by licensed therapists.

Other: Guidline-basaed massage therapy

Control group (CG)

ACTIVE COMPARATOR

Participants receive Swedish massage

Other: Swedish massage

Interventions

Massage protocol based on guidelines from the Polish Society of Physiotherapy, the Polish Society of Family Medicine, the College of Family Physicians in Poland, and the European Rural and Isolated Practitioners

Guideline-Based Massage Therapy (GMT)Guideline-Based Massage Therapy + Self-Massage Group (GMT+SM)

A classical form of therapeutic massage that uses a combination of long, flowing strokes, kneading, friction, tapping, and gentle stretching to promote relaxation, improve circulation, and reduce muscle tension. It is typically performed using oil or lotion to reduce friction on the skin. Techniques are applied with light to moderate pressure and are designed to enhance general well-being and support recovery from muscular discomfort or stress

Control group (CG)

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult healthcare workers
  • Aged 30-65 years with chronic nonspecific low back pain for ≥3 months
  • No medical contraindications to massage therapy
  • Body mass index (BMI) between 18.5 and 25 kg/m²
  • Provided written informed consent

You may not qualify if:

  • Massage therapy within the past 3 months
  • Contraindications to massage therapy
  • Ongoing physical therapy
  • Significant medical or psychiatric conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniwersytecki Szpital Kliniczny we Wrocławiu

Wroclaw, Lower Silesian Voivodeship, Poland

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Krzysztof K Principal Investigator

    Department of Massage and Physiotherapy, Wroclaw University of Health and Sport Sciences, Wroclaw, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, three-arm, parallel-group, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 29, 2025

First Posted

July 31, 2025

Study Start

July 31, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations