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NCT Number: NCT05181579

Efficacy of Manual Therapy and Sacroiliac Joint Injection in Sacroiliac Joint Dysfunction

The purpose of this study is to compare the efficacy of manual therapy and sacroiliac joint injections in patients with sacroiliac joint dysfunction

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Key information

Conditions

Sacroiliac Joint Somatic Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months
  • Pain score greater than 3 according to NRS
  • Unresponsiveness to conservative treatment (such as exercise, NSAID)
  • At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive

Exclusion criteria

  • Refusing to participate in the study
  • Pregnancy
  • History of inflammatory disease (ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, etc.)
  • Infective sacroiliitis
  • Malignancy
  • Osteoporosis
  • Mechanical lumbosacral pathologies (spondylolisthesis, scoliosis, stenosis, etc.)
  • Neurological finding in the lower extremity
  • Pain spreading below the knee
  • History of spinal surgery
  • History of allergy to drugs to be injected (local anesthetic, contrast material, steroid allergy)

Treatment and study plan

Manuel therapy

Other

Some sacroiliac manipulation and mobilization techniques will be applied to patients by an experienced physiatrist. Patients in the manual therapy group will receive 5 sessions of sacroiliac joint manipulation once a week.

Sacroiliac joint injection

Other

Corticosteroid (1 ml 40 mg methylprednisolone) and local anesthetic (1 ml 1% lidocaine) will be injected into the sacroiliac joint using a 22 G spinal needle, guided by fluoroscopy (C-arm fluoroscopy) by an experienced physiatrist. It will be applied just one time.

Primary outcomes

  1. Numeric Rating Scale, NRS

    Time frame: Change from baseline NRS at 3 months

    NRS is an 11-grade scale that evaluates the severity of pain in adults .NRS is one of the most commonly used scales in the assessment of pain severity. Possible scores ranges from 0( no pain) to 10 ( worst pain)

Secondary outcomes

  1. Oswestry Disability index

    Time frame: Baseline, Month 1, Month 3, Month 6

    The Oswestry disability index will be used to evaluate how much the patients' low back pain limits their activities in daily life. This index was first created in 1980 . The questionnaire consists of 10 sections, each assessing limitations in different daily activities and functions. Each section is scored from 0 to 5. A score of 0 indicates that there is no restriction while doing that activity, while a score of 5 represents the highest level of restriction in that activity. The maximum score is 50. As the total score increases, the disability level of the individual increases. In 2004, Turkish validity study was carried out by Yakut et al.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

Efficacy of Manual Therapy and Sacroiliac Joint Injection in the Treatment of Patients With Sacroiliac Joint Dysfunction

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2022
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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