Comparison of the Effectiveness of Chiropractic Manipulation Applied to the Lumbar Sacroiliac Region in Patients With Lumbar Disc Herniation (CLuSH)

September 16, 2025 updated by: SEFA HAKTAN HATIK
This study aims to compare the effectiveness of chiropractic manipulation applied to the lumbar and sacroiliac regions in patients with lumbar disc herniation. A total of 45 participants are randomly assigned into three groups (15 per group). The control group (CG) receives conventional physiotherapy, including hot pack, TENS, ultrasound, and exercise. The lumbar group (LG) receives the same physiotherapy program combined with lumbar spinal manipulation. The sacroiliac group (SIG) receives conventional physiotherapy combined with sacroiliac joint manipulation. Outcomes are measured using the Numeric Pain Rating Scale (NPRS), Quebec Back Pain Disability Scale, Tampa Scale for Kinesiophobia, and range of motion (ROM) assessments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial investigates the comparative effectiveness of regional chiropractic manipulation in patients diagnosed with lumbar disc herniation. The study includes three groups, each consisting of 15 participants. All groups receive a standard physiotherapy protocol, including hot pack application, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and exercise therapy.

The Control Group (CG) receives only the standard physiotherapy program. The Lumbar Group (LG) receives standard physiotherapy in combination with lumbar spinal manipulation.

The Sacroiliac Group (SIG) receives standard physiotherapy in combination with sacroiliac joint manipulation.

Interventions are delivered by licensed practitioners following standardized protocols. The study aims to evaluate the effects of region-specific chiropractic manipulations on pain intensity, functional disability, kinesiophobia, and lumbar range of motion. Assessments are conducted at baseline and at the end of the treatment period using validated measurement tools: the Numeric Pain Rating Scale (NPRS), Quebec Back Pain Disability Scale, Tampa Scale for Kinesiophobia, and goniometric range of motion measurements.

By comparing outcomes across these three groups, the study seeks to identify whether regionally targeted chiropractic manipulation enhances the clinical efficacy of conventional physiotherapy in managing lumbar disc herniation.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be between the ages of 18 and 65
  • Have been diagnosed with lumbar disc herniation
  • Have signed the voluntary consent form

Exclusion Criteria:

  • Having a value below 4 according to the NAS
  • Having a contraindication to chiropractic manipulation
  • Having a rheumatic disease
  • Having undergone surgery in the lumbar and sacroiliac regions
  • Being pregnant or suspected of being pregnant
  • Having a malignant disease
  • Having severe physical and psychological disorders
  • Having acute fractures of the spine and lower extremities fractures in the lower extremities
  • Individuals with neurological and orthopedic deficits in the lower extremities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lumbar Region Group (LBG)
Participants in the lumbar manipulation group will receive the same conventional physiotherapy program as the control group (hot pack, TENS, ultrasound, and exercise therapy), along with high-velocity low-amplitude (HVLA) chiropractic manipulation applied specifically to the lumbar spine. The lumbar manipulation will be administered twice per week, totaling four sessions over a two-week period.
Other: Lumbar Spine Manipulation
Painful lumbar segments will be identified through palpation of the spinous and transverse processes. Patients will be positioned side-lying with head supported by a pillow. The lower arm will rest across the chest, and the lower leg will be extended while the upper leg will be flexed, with the foot placed in the popliteal space. The practitioner will assume a 45-degree angled stance, stabilizing the patient's pelvis between their thighs. The hypothenar eminence will contact the mammillary process of the dysfunctional vertebra, while the opposite hand stabilizes the upper shoulder. A high-velocity, low-amplitude (HVLA) thrust will be applied in a rotational direction toward the patient's umbilicus. This technique will be performed twice per week for two weeks (4 sessions total), alongside conventional physiotherapy (hot pack, TENS, ultrasound, and exercise).
Experimental: Sacroiliac Joint Manipulation Group (SEG)
Participants in the sacroiliac joint manipulation group will receive the standard physiotherapy protocol (hot pack, TENS, ultrasound, and exercise therapy) in combination with high-velocity low-amplitude (HVLA) chiropractic manipulation targeted at the sacroiliac (SI) joint. The SI joint manipulation will be performed twice weekly, for a total of four sessions over two weeks.
Other: Sacroiliac Joint Manipulation
The side for sacroiliac joint manipulation will be determined using the Derifield leg length test. Based on functional leg length differences, a PI (posterior-inferior) ilium will be identified. Patients will be positioned side-lying with appropriate limb and trunk alignment. The practitioner's hypothenar eminence will be placed on the PSIS of the dysfunctional side. A high-velocity, low-amplitude (HVLA) thrust will be applied in a rotational direction from the PSIS toward the patient's umbilicus to correct the joint dysfunction. The manipulation will be performed twice a week over two weeks (4 sessions in total), combined with conventional physiotherapy (hot pack, TENS, ultrasound, and exercise).
Active Comparator: Control Group (CG)
Participants in the control group will receive conventional physiotherapy consisting of hot pack application, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, and supervised exercise therapy. These treatments will be applied regularly over a two-week period. No chiropractic or manual therapy will be administered in this group.
Other: Conventional Physiotherapy
Conventional physiotherapy will consist of hot pack, TENS, therapeutic ultrasound, and supervised exercises applied over two weeks (6 sessions/week). Hot packs filled with silicate gel will be wrapped in four towel layers and applied for 20 minutes with the patient prone and a pillow under the abdomen. TENS will be delivered via Chattanooga Intelect device with a symmetrical biphasic program for 30 minutes using four electrodes placed on the treatment area. Ultrasound will be applied continuously for 3 minutes with the same device. Patients will be instructed on lumbar mobility and strengthening exercises, performed twice daily with 15 repetitions each. No spinal or sacroiliac manipulation will be performed in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity (Numeric Pain Rating Scale - NPRS / NRS)
Time Frame: Baseline and at the end of 2 weeks
Pain intensity will be assessed using the Numeric Pain Rating Scale (0-10), where higher scores indicate more severe pain.
Baseline and at the end of 2 weeks
Functional Disability (Quebec Back Pain Disability Scale)
Time Frame: Baseline and at the end of 2 weeks
Functional disability due to low back pain will be measured using the Quebec Back Pain Disability Scale. Higher scores indicate greater disability.
Baseline and at the end of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinesiophobia (Tampa Scale of Kinesiophobia - TSK)
Time Frame: Baseline and at the end of 2 weeks
The Tampa Scale of Kinesiophobia will be used to assess fear of movement or re-injury. Higher scores indicate more severe kinesiophobia.
Baseline and at the end of 2 weeks
Lumbar Range of Motion (ROM) Measurements
Time Frame: Baseline and at the end of 2 weeks
Lumbar flexion, extension, lateral flexion, and rotation will be measured using a goniometer to evaluate changes in spinal mobility.
Baseline and at the end of 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SEFA HAKTAN HATIK

Investigators

  • Principal Investigator: SEFA H HATIK, Asst. Prof., Sinop University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2025

Primary Completion (Actual)

July 20, 2025

Study Completion (Actual)

August 20, 2025

Study Registration Dates

First Submitted

June 17, 2025

First Submitted That Met QC Criteria

June 17, 2025

First Posted (Actual)

June 25, 2025

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMT0008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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