CompletedNot Applicable

Comparison of the Effect of Spinal Manipulation by Gender

Turkey (Türkiye)62 participantsStarted 2024-04-01

Plain-language summary

The purpose of the study was to compare and evaluate the effects of spinal manipulation in patients with chronic mechanical low back pain by gender.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosed with chronic mechanical low back pain * Between the ages of 18 and 50 * Read and speak Turkish well enough to give informed consent and follow study instruction * Being able to come for outpatient manipulation treatment * Body mass index below 28 Exclusion Criteria: * Currently involved in a legal proceeding related to back pain for which a workers' compensation claim is pending and have or have applied for permanent disability related to these problems * Pregnancy * Having any kind of malignancy * Having any kind of osteoplastic disorders * Having osteomyelitis, septic intervertebral discs and TB * History of a spinal fracture and stenosis * Inflammatory low back pain * History of severe osteoporosis * History of any kind of bleeding disorders * Taking steroids, anticoagulants, paracetamol, antidepressant drugs or drug-like substances * Having any orthopedic and/or rheumatologic disease affecting the pelvic region * Conservative or physical therapy for the lumbar region for the past 6 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analog Scale

Timeframe: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).

World Health Organization Quality-of-Life Scale (WHOQOL-BREF)

Timeframe: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).

Oswetry Disability Index (ODI)

Timeframe: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).

Pittsburgh Sleep Quality Index (PSQI)

Timeframe: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).

McGill Pain Questionnare (MGPQ)

Timeframe: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).

Treatment Satisfaction Score

Timeframe: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).

Trial details

NCT IDNCT06578208

SponsorSEFA HAKTAN HATIK

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-01

View on ClinicalTrials.gov More Mechanical Low Back Pain trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Visual Analog Scale

Timeframe: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).

World Health Organization Quality-of-Life Scale (WHOQOL-BREF)

Timeframe: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).

Oswetry Disability Index (ODI)

Timeframe: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).

Pittsburgh Sleep Quality Index (PSQI)

Timeframe: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).

McGill Pain Questionnare (MGPQ)

Timeframe: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).

Treatment Satisfaction Score

Timeframe: This questionnaire was conducted at the beginning of treatment, at the end of treatment (week 8) and 1 month after the end of treatment (week 12).