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

NCT ID: NCT07037641

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2025-08-20

Brief Summary

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.

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.

Conditions

Spinal Manipulation; Chiropractic; Lumbal Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lumbar Spine Manipulation

Intervention Type: OTHER

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).

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.

Group Type: EXPERIMENTAL

Sacroiliac Joint Manipulation

Intervention Type: OTHER

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).

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.

Group Type: ACTIVE_COMPARATOR

Conventional Physiotherapy

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SEFA HAKTAN HATIK

OTHER

Sponsor Role: lead

Responsible Party

SEFA HAKTAN HATIK

Asst. Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

SEFA H HATIK, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Sinop University

Locations

Sinop University

Sinop, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CMT0008

Identifier Type: -

Identifier Source: org_study_id