Pragmatically Applied Orthopedic Manual Therapy and Dry Needling for Low Back Pain.

NCT06150625 | Unknown

• 1 other identifier: 2024-35
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

Brief Summary

Both orthopedic manual therapy (OMT) and dry needling (DN) have been shown to be effective at reducing pain and disability for individuals with low back pain (LBP). It is unclear if one intervention, or in combination with one another, is more effective. The purpose of this randomized clinical trial is to determine the clinical effectiveness of OMT or DN alone compared with combined OMT + DN on pain and disability for patients with LBP. Both within and between group effects will be presented. Patient factors such as; generalized anxiety disorder, depression, fear-avoidance behaviors, pain catastrophizing, and sleep-quality have negatively correlated with pain and disability outcomes in patients experiencing chronic LBP. Moreover, sleep deprivation and pain related fear of movement functionally can change a person's pain inhibitory pathways leading to hyeralgesia. These factors have been individually analyzed regarding their effects on pain related outcomes, which limits our understanding of how clustering patient factors might affect recovery. A secondary aim will involve determining the relationship between patient factors and clinical outcomes for individuals with LBP who receive DN and/or manual therapy.

Conditions

Low Back Pain, Mechanical

Keywords

Low back pain, manual therapy, dry needling

Outcome Measures

Primary Outcomes (1)

• PROMIS-29.2

  Questionnaire that assesses 7 domains with 4 questions with an additional pain intensity numeric rating scale (NPRS). The PROMIS measures have been tested and validated in large reference populations making them suitable for research on different conditions.

  Baseline, 1 week, 1 month, and 6 months

Secondary Outcomes (3)

• Global Rating of Change

  1 week, 1 month, and 6 months

• Global Rating of Change for Medication Intake

  1 week, 1 month, and 6 months

• Health Care Utilization

  6 months

Other Outcomes (3)

• Patient Treatment Preference

  Baseline

• Clinician Treatment Preference

  Baseline

• Credibility Expectancy Questionnaire

  Baseline

Study Arms (3)

Orthopedic Manual Therapy

ACTIVE COMPARATOR

Participants randomized to this arm will receive clinician-selected orthopedic manual therapy targeting the joints of the low back. Selected techniques can involve joint mobilizations or spinal manipulation. The dosage parameters will be determined by the clinician. Patient Education Patients will receive education regarding their low back pain, advice to stay active, proper performance of their home exercise program. Home exercise program The program will consist of 10 exercises which the clinician will select 5 they feel would be most beneficial to the patient. These can include aerobic, general strengthening, directional preference, or neural self-mobilizations.

Other: Orthopedic Manaual Therapy; Other: Home exercise program; Other: Patient education

Dry Needling

ACTIVE COMPARATOR

Participants randomized to this arm will receive dry needling to the low back and lower extremity while being applied based on clinician-selected areas of symptomatic soft tissue. The dosage parameters will be determined by the clinician. Patient Education Patients will receive education regarding their low back pain, advice to stay active, proper performance of their home exercise program. Home exercise program The program will consist of 10 exercises which the clinician will select 5 they feel would be most beneficial to the patient. These can include aerobic, general strengthening, directional preference, or neural self-mobilizations.

Other: Dry Needling; Other: Home exercise program; Other: Patient education

Orthopedic Manual Therapy and Dry needling

EXPERIMENTAL

Participants randomized to this arm will receive dry needling to the lumbar spine and lower extremity based on clinician-selected areas of symptomatic soft-tissue and or orthopedic manual therapy targeting the joints of the low back. Patient Education Patients will receive education regarding their low back pain, advice to stay active, proper performance of their home exercise program. Home exercise program The program will consist of 10 exercises which the clinician will select 5 they feel would be most beneficial to the patient. These can include aerobic, general strengthening, directional preference, or neural self-mobilizations.

Other: Orthopedic Manaual Therapy; Other: Dry Needling; Other: Home exercise program; Other: Patient education

Interventions

Orthopedic Manaual Therapy OTHER

Can include either spinal mobilizations or spinal manipulation therapy targeting the stiff or symptomatic level of the lumbar spine. Various types of mobilization or manipulation may be used based on the therapists clinical reasoning. The therapist will determine which technique and dosage parameters for each subject based on individual patient clinical data. Common mobilizations techniques involve gently and repeatedly applying pressure over different parts of the patient's spine that is associated with their symptoms. For a manipulation, the patient will be positioned in side-lying position. The therapist will then position the patient further to target the symptomatic level. The patient is asked to take a deep breathe in and out. The therapist will slowly add pressure through the trunk and apply a fast but small thrust motion toward the table.

Orthopedic Manual Therapy; Orthopedic Manual Therapy and Dry needling

Dry Needling OTHER

dry needling both sides of the symptomatic level(s) of the lumbar spine as well as needling other areas in the lower extremity and pelvis based on the results of their clinical evaluation and/or the subjects presenting symptoms. Dry needling involves the insertion of a monofilament needle (nothing is injected) into symptomatic soft tissue. The therapist will determine which technique and dosage parameters for each subject based on individual patient clinical data.

Dry Needling; Orthopedic Manual Therapy and Dry needling

Home exercise program OTHER

5 exercises will be selected from 10 options intended to reinforce the improvements made from treatment.

Dry Needling; Orthopedic Manual Therapy; Orthopedic Manual Therapy and Dry needling

Patient education OTHER

Patient education on the low back condition, advice to stay active, and home exercise performance.

Dry Needling; Orthopedic Manual Therapy; Orthopedic Manual Therapy and Dry needling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are 18 years of age or older, present with LBP and a pain score of \> or = 3/10

You may not qualify if:

• Patients will be excluded if they present with a contraindication to either treatment (malignancy, fracture, myelopathy, osteoporosis, etc.), have a prior surgical history involving the lumbar spine, present with spinal nerve root compression (2 or more neurological findings that includes myotome weakness, dermatomal sensory loss, and/or deep tendon reflexive changes), are seeking litigation, or are receiving other forms of conservative care.

Sponsors & Collaborators

• Youngstown State University: lead
• Duke University: collaborator

Related Publications (4)

• Rubinstein SM, de Zoete A, van Middelkoop M, Assendelft WJJ, de Boer MR, van Tulder MW. Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials. BMJ. 2019 Mar 13;364:l689. doi: 10.1136/bmj.l689.

  PMID: 30867144 BACKGROUND

• Hu HT, Gao H, Ma RJ, Zhao XF, Tian HF, Li L. Is dry needling effective for low back pain?: A systematic review and PRISMA-compliant meta-analysis. Medicine (Baltimore). 2018 Jun;97(26):e11225. doi: 10.1097/MD.0000000000011225.

  PMID: 29952980 BACKGROUND

• Corp N, Mansell G, Stynes S, Wynne-Jones G, Morso L, Hill JC, van der Windt DA. Evidence-based treatment recommendations for neck and low back pain across Europe: A systematic review of guidelines. Eur J Pain. 2021 Feb;25(2):275-295. doi: 10.1002/ejp.1679. Epub 2020 Nov 12.

  PMID: 33064878 BACKGROUND

• Owen PJ, Miller CT, Mundell NL, Verswijveren SJJM, Tagliaferri SD, Brisby H, Bowe SJ, Belavy DL. Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis. Br J Sports Med. 2020 Nov;54(21):1279-1287. doi: 10.1136/bjsports-2019-100886. Epub 2019 Oct 30.

  PMID: 31666220 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling; Patient Education as Topic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

David W Griswold, PhD

CONTACT

330-941-2419; dwgriswold@ysu.edu

Ken E Learman, PhD

CONTACT

330-941-725; Klearman@ysu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All data will be collected through REDcap. The treating therapist will have no knowledge pertaining to the outcomes being collected.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The outcome assessor needing access to REDcap will be blinded the treatment group. The clinician providing treatment will be blinded to outcomes.

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 29, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share