Spinal ManipulationCLuSHNCT07037641
Comparison of the Effectiveness of Chiropractic Manipulation Applied to the Lumbar Sacroiliac Region in Patients With Lumbar Disc Herniation
A study testing Lumbar Spine Manipulation, Sacroiliac Joint Manipulation and Conventional Physiotherapy in people with Spinal Manipulation and Chiropractic, run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Manipulation, Chiropractic, Lumbal Disc Herniation
- What is being tested?
- Lumbar Spine Manipulation, Sacroiliac Joint Manipulation and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2025to 20 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be between the ages of 18 and 65
- Have been diagnosed with lumbar disc herniation
- Have signed the voluntary consent form
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Lumbar Spine Manipulation, Sacroiliac Joint Manipulation, Conventional Physiotherapy
- Keywords
- Spinal Manipulation, Chiropractic, Lumbal Disc Herniation, Physiotherapy, Disc Pathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Spine ManipulationOther
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 ManipulationOther
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).
Conventional PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Region Group (LBG) | Experimental | 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. Receives: Other: Lumbar Spine Manipulation |
| Sacroiliac Joint Manipulation Group (SEG) | Experimental | 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. Receives: Other: Sacroiliac Joint Manipulation |
| Control Group (CG) | Active comparator | 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. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (Numeric Pain Rating Scale - NPRS / NRS)
Pain intensity will be assessed using the Numeric Pain Rating Scale (0-10), where higher scores indicate more severe pain.
Measured: Baseline and at the end of 2 weeks
Functional Disability (Quebec Back Pain Disability Scale)
Functional disability due to low back pain will be measured using the Quebec Back Pain Disability Scale. Higher scores indicate greater disability.
Measured: Baseline and at the end of 2 weeks
Secondary outcomes (2)
Kinesiophobia (Tampa Scale of Kinesiophobia - TSK)
The Tampa Scale of Kinesiophobia will be used to assess fear of movement or re-injury. Higher scores indicate more severe kinesiophobia.
Measured: Baseline and at the end of 2 weeks
Lumbar Range of Motion (ROM) Measurements
Lumbar flexion, extension, lateral flexion, and rotation will be measured using a goniometer to evaluate changes in spinal mobility.
Measured: Baseline and at the end of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start20 Jun 2025
- Primary completion20 Jul 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal ManipulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEFA HAKTAN HATIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SEFA HAKTAN HATIK, Sinop University
- Investigators
- SEFA H HATIK, Asst. Prof., Principal investigator, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037641
- Sponsor's protocol ID
- CMT0008
- Acronym
- CLuSH
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Chiropractic Manipulation Applied to the Lumbar Sacroiliac Region in Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT07037641
- Acronym / sponsor ID
- CLuSH / CMT0008
- Conditions
- Spinal Manipulation, Chiropractic, Lumbal Disc Herniation
- Keywords
- Spinal Manipulation, Chiropractic, Lumbal Disc Herniation, Physiotherapy, Disc Pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- SEFA HAKTAN HATIKUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumbar Region Group (LBG) | Experimental | Other: Lumbar Spine ManipulationParticipants 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. |
| Sacroiliac Joint Manipulation Group (SEG) | Experimental | Other: Sacroiliac Joint ManipulationParticipants 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. |
| Control Group (CG) | Active comparator | Other: Conventional PhysiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be between the ages of 18 and 65
- Have been diagnosed with lumbar disc herniation
- Have signed the voluntary consent form
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar Spine ManipulationPainful 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). | Other | Lumbar Region Group (LBG) |
| Sacroiliac Joint ManipulationThe 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). | Other | Sacroiliac Joint Manipulation Group (SEG) |
| Conventional PhysiotherapyConventional 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. | Other | Control Group (CG) |
Primary outcome
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.
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.
2 secondary outcomes
Kinesiophobia (Tampa Scale of Kinesiophobia - TSK)
Time frame: Baseline and at the end of 2 weeks
Lumbar Range of Motion (ROM) Measurements
Time frame: Baseline and at the end of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Spinal Manipulation
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Cervical SNAGs With and Without Thoracic Manipulation on Neck Pain and Disability in Smartphone Users
Non Specific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.
Back Pain Lower Back Chronic
Not yet recruiting
Lumbar Spinal Manipulation in Stroke
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SEFA H HATIK, Asst. Prof. principal investigator
Sinop University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Spine Manipulation, Sacroiliac Joint Manipulation and Conventional Physiotherapy in people with Spinal Manipulation and Chiropractic, run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Numeric Pain Rating Scale - NPRS / NRS) (time frame: Baseline and at the end of 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.