NCT07362420

Brief Summary

The goal of this clinical trial is to learn if two common physical therapy approaches, used alone or together, can help reduce pain and improve daily function in adults with nonspecific low back pain. Nonspecific low back pain means low back pain without a clear medical cause. The main questions this study aims to answer are:

  • Be assigned to one of the three treatment groups by chance
  • Receive treatment twice a week for four weeks
  • Complete simple assessments before treatment starts, after the first treatment session, and after the final session The results of this study may help physical therapists choose better noninvasive treatment options for people with nonspecific low back pain.

Trial Health

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Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Progress32%
Jan 2026Nov 2026

First Submitted

Initial submission to the registry

January 7, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 7, 2026

Last Update Submit

January 15, 2026

Conditions

Keywords

Non-specific Low Back PainLow Back PainMyofascial Trigger PointsMyofascial ChainExercise TherapyManual TherapyPhysical Therapy

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    Pain intensity is assessed using the Numeric Pain Rating Scale (NPRS). Participants rate their current low back pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Lower scores indicate less pain.

    Baseline (before the first treatment session), immediately after the first treatment session, and after the final treatment session (4 weeks)

Secondary Outcomes (8)

  • Functional performance

    Baseline (before the first treatment session) and after the final treatment session (4 weeks)

  • Low Back Pain-Related Disability

    Baseline (before the first treatment session) and after the final treatment session (4 weeks)

  • Myofascial Chain Extensibility

    Baseline (before the first treatment session) and after the final treatment session (4 weeks)

  • Myofascial Chain Endurance

    Baseline (before the first treatment session) and after the final treatment session (4 weeks)

  • Muscle Function

    Baseline (before the first treatment session) and after the final treatment session (4 weeks)

  • +3 more secondary outcomes

Study Arms (3)

Myofascial Trigger Point Manual Compression Group

EXPERIMENTAL

Participants in this group receive myofascial trigger point manual compression only. A licensed physical therapist applies sustained manual pressure to identified myofascial trigger points using standardized, noninvasive procedures.

Other: Myofascial Trigger Point Manual Compression

Myofascial Chain-Based Specific Exercise Group

EXPERIMENTAL

Participants in this group receive a myofascial chain-based specific exercise program only. The supervised exercise program is delivered by a physical therapist and focuses on movement control and muscle function within targeted myofascial chains.

Other: Myofascial Chain-Based Specific Exercise

Combined Manual Compression and Exercise Group

EXPERIMENTAL

Participants in this group receive a combined intervention consisting of myofascial trigger point manual compression followed by a myofascial chain-based specific exercise program within the same treatment session.

Other: Myofascial Trigger Point Manual CompressionOther: Myofascial Chain-Based Specific Exercise

Interventions

This intervention consists of noninvasive hands-on manual pressure applied by a licensed physical therapist to identified myofascial trigger points associated with nonspecific low back pain. Treatment sessions are provided twice per week over a four-week period. Manual compression is applied using standardized clinical procedures at an intensity tolerated by the participant. The selection of trigger points follows predefined criteria to ensure consistency across treatment sessions. This intervention is noninvasive and does not involve the use of any drugs or medical devices.

Combined Manual Compression and Exercise GroupMyofascial Trigger Point Manual Compression Group

This intervention is a supervised, noninvasive exercise program delivered by a licensed physical therapist. Participants attend exercise sessions twice per week for four weeks. The program focuses on movement control and muscle function within targeted myofascial chains and is tailored based on functional muscle performance. Exercise selection and progression follow standardized clinical criteria to promote safe and consistent implementation. This intervention is noninvasive and does not involve the use of any drugs or medical devices.

Combined Manual Compression and Exercise GroupMyofascial Chain-Based Specific Exercise Group

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 to 65 years
  • Nonspecific low back pain lasting longer than 6 weeks
  • Average low back pain intensity of 3 or higher on a 0-10 Numeric Pain Rating Scale
  • Presence of at least 6 myofascial trigger points identified across bilateral target muscles
  • Presence of muscle function impairments in at least 6 muscle groups based on functional muscle testing
  • Able to understand study procedures and participate in an exercise-based intervention
  • Willing and able to attend treatment sessions and complete study assessments

You may not qualify if:

  • Currently pregnant
  • Diagnosed spondylolisthesis or vertebral compression fracture
  • Known malignancy or history of cancer affecting the spine
  • Previous lumbar spine surgery
  • Known neurological, infectious, or systemic disease that may affect pain or movement
  • Any other medical condition that, in the opinion of the investigators, would interfere with safe participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, Taipei City, 112304, Taiwan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Physical Therapy, National Yang Ming Chiao Tung University

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 23, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

There is currently no plan to share individual participant data. This decision may be re-evaluated upon study completion or at the time of publication.

Locations