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

Low Back Pain, Mechanical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06150625
• Other study ID #: 2024-35
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Youngstown State University
• Contact: David W Griswold, PhD
• Phone: 330-941-2419
• Email: dwgriswold[@]ysu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Low back pain (LBP) is a common disorder, (GBD,2016) placing a tremendous financial burden on the health care and occupational systems. (Freburg,2009) The etiology and influences to chronic LBP remains unknown due to multiple interacting factors involving pain, disability, psychosocial, and psychological factors. While the search for effective therapies has been ongoing in clinical trials, the optimal management strategies remain elusive due to inconsistent findings in randomized clinical trials (RCT) and systematic reviews. (Bussieres,2018; Coulter, 2018;Kamper, 2015)

Orthopedic manual therapy is routinely used to assist patients with LBP manage their symptoms. (George, 2021) Mechanisms identified in pre-clinical studies involve local, segmental, and systemic neurophysiological changes helping reduce pain.(Bialosky,2018) Two popular forms of orthopedic manual therapy are spinal manipulation/mobilization therapy and dry needling (DN). While these treatments share mechanisms of action, DN also creates a physiological lesion resulting in mechanical disruption of connective tissue to deeper structures. Clinical Practice Guidelines recommend both OMT and DN be incorporated as part of a multimodal treatment plan.(George,2021) It is unknown if these treatments combined produce larger treatment effects than when they are applied individually. While this treatment combination has been investigated for other musculoskeletal conditions (Dunning, 2021a; Dunning, 2021b; González-Iglesias,2013; Gattie, 2021), it has not been studied for LBP.

Patient Factors that Influence Outcomes 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. (Alhowimel,2018) A recent multimodal metanalysis involving patients with depressive/anxiety disorders with chronic pain observed disorder specific neurological changes on functional MRI, exploiting neuro-behavioral mechanisms. (Brandl 2022) Moreover, sleep deprivation and pain related fear of movement functionally can change a person's pain inhibitory pathways leading to hyeralgesia. (Finan 2013; Meier, 2017) 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. We hypothesize that certain combinations of patient factors will correlate with those patients with chronic LBP who were less likely to experience a clinically meaningful change in pain and disability.

Statement of the Problems

Problem 1: The most effective conservative management strategies for patients with LBP remains unknown. Manual therapy is routinely used in clinical practice and recommended in Clinical Practice Guidelines, including OMT and DN. It is unknown if a pragmatically applied OMT combined with DN produces larger treatment effects than a pragmatically applied SMT alone for patients with LBP.

Problem 2: Patient factors such as psychological and psychosocial factors, patient recovery expectations, and patient treatment preferences have all demonstrated the ability to influence clinical outcomes in patients with LBP. Currently it is not understood how the presence of multiple patient variables combine to interact with patient outcomes.

Purpose Statement The purpose of this randomized clinical trial is to determine the clinical effectiveness of OMT or DN alone compared with OMT and DN on pain and disability for patients with LBP. Both within and between group effects will be presented. Our hypothesis is that individuals treated with both OMT and DN will experience greater changes in pain and disability compared with those who receive either treatment individually. We also anticipate the presence of patient factors known to influence pain will negatively correlate with patient outcomes and certain combinations of these patient factors may have a stronger influence on clinical outcomes.

Statement of Research Objectives

Specific Aim 1: Determine the comparative effectiveness of pragmatically applied OMT with DN compared to OMT or DN alone for patients with LBP and disability.

Specific Aim 2: Determine the relationship between patient factors and clinical outcomes for individuals with LBP who receive DN and/or OMT.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 188
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

Other:
• Orthopedic Manaual Therapy
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.
• Dry Needling
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.
• Home exercise program
5 exercises will be selected from 10 options intended to reinforce the improvements made from treatment.
• Patient education
Patient education on the low back condition, advice to stay active, and home exercise performance.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Youngstown State University	Duke University

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Treatment Preference	The patient rates their preference for treatment between dry needling, orthopedic manual threrapy, or both.	Baseline
Other	Clinician Treatment Preference	The clinician rates their preference for treatment between dry needling, orthopedic manual threrapy, or both.	Baseline
Other	Credibility Expectancy Questionnaire	Scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies.	Baseline
Primary	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	Global Rating of Change	Questionnaire that assesses the global degree of change the patient perceives since the start of care.; The patient rates their change from 0 (no change) to +7 (A Very Great Deal Better) to -7 (A Very Great Deal Worse)	1 week, 1 month, and 6 months
Secondary	Global Rating of Change for Medication Intake	Questionnaire that assesses the global degree of change in pain medication the patient experienced since the start of care. The patient rates their change in medications from 0 (no change) to +7 (A Very Great Deal Less) to -7 (A Very Great Deal More)	1 week, 1 month, and 6 months
Secondary	Health Care Utilization	Patients will report any providers they had to see after the completion of the study to 6 months for their low back problem.	6 months