Comparing Dry Needling to Manual Therapy for Patients With Mechanical Low Back Pain

NCT02312895 | Completed

• 1 other identifier: 159-14
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This is a comparative study to determine if there is a difference in pain reduction and disability between dry needling and manual therapy for patients with low back pain. Subjects will be seen two times per week for 3 weeks (6 visits) and will receive either dry needling or manual mobilizations along with patient education and a home exercise program.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (change over time)

  The ODI is a ten question self report measure that assesses the impact of the patient's pain on their ability to perform everyday activities and is currently considered the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain.

  The ODI will be recorded at baseline, 1 week, 2 weeks, and discharge/3 weeks.

Secondary Outcomes (4)

• Numerical Pain Rating Scale (change over time)

  The NPRS will be recorded at baseline, immediately following treatment, at 1 week, 2 weeks, and discharge/3 weeks.

• Pain pressure threshold (change over time)

  The NPRS will be recorded at baseline, immediately following treatment, at 1 week, 2 weeks, and discharge/3 weeks.

• Percentage of recovery (one time assessment at the end of the 3 weeks)

  3 weeks or Discharge

• Patient Specific Functional Scale Score

  PSFS score collected at baseline, 1 week, 2 weeks, and 3 weeks or discharge

Study Arms (2)

Dry Needling

EXPERIMENTAL

A total of 30 subjects will be randomized to this experimental arm. If randomized to this arm, subjects will receive dry needling, patient education, and a home exercise program.

Other: Dry needling; Other: Home Exercise Program

Manual Therapy

EXPERIMENTAL

A total of 30 subjects will be randomized to this experimental arm. If randomized to this arm, subjects will receive manual therapy, patient education, and a home exercise program.

Other: Manual therapy; Other: Home Exercise Program

Interventions

Manual therapy OTHER

The therapist will locate the involved segment using passive accessory intervertebral movements. The segment will be localized to the level, which provokes the patient's symptoms most easily, and this segment will be determined to be the involved level. Once this level has been identified, the therapist will compare central glides over the spinous process or a unilateral glide over the facet joint to determine which is more provocative. Whichever is most provocative will be the location of the treatment. The therapist will provide 3 bouts lasting 45 seconds just easing into the patient's symptoms at the most provocative level with approximately 45 seconds rest between each bout.

Manual Therapy

Dry needling OTHER

Dry needling involves inserting a dry, mono-filament needle through the skin and into an area of symptomatic soft tissue. The two-inch needles will be placed segmentally and into the lower extremities following peripheral nerve patterning by the treating physical therapist. Following initial penetration into the skin over the tender area, the therapist carefully advances the needle into the tissue below the skin. After the needle has reached the desired depth, the therapist will insert the subsequent needles. Needles will be placed along the segmental levels of the lumbar spine above and below the tender area identified and into the lower extremity in areas that correlate with a peripheral nerve map. Needles will remain in the tissue for up to 5 minutes, removed, and appropriately disposed of.

Dry Needling

Home Exercise Program OTHER

A home exercise program will be given to each subject to be completed in the clinic and at home 1x/day. The exercises will consist of active range of motion exercises and core stabilization exercises. The program is standardized for all subjects.

Dry Needling; Manual Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• There will be 72 subjects participating in this study that present with mechanical low back pain, ranging from 18-70 years old. The 72 subjects includes a 20% attrition rate 12 additional subjects. The total needed for analysis is 60 subjects, 30 per group.

Sponsors & Collaborators

• Youngstown State University: lead

Study Sites (1)

Youngstown state university

Youngstown, Ohio, 44406, United States

Location

Related Publications (3)

• Furlan AD, van Tulder M, Cherkin D, Tsukayama H, Lao L, Koes B, Berman B. Acupuncture and dry-needling for low back pain: an updated systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976). 2005 Apr 15;30(8):944-63. doi: 10.1097/01.brs.0000158941.21571.01.

  PMID: 15834340 BACKGROUND

• Ziaeifar M, Arab AM, Karimi N, Nourbakhsh MR. The effect of dry needling on pain, pressure pain threshold and disability in patients with a myofascial trigger point in the upper trapezius muscle. J Bodyw Mov Ther. 2014 Apr;18(2):298-305. doi: 10.1016/j.jbmt.2013.11.004. Epub 2013 Nov 9.

  PMID: 24725800 BACKGROUND

• Cook C, Learman K, Showalter C, Kabbaz V, O'Halloran B. Early use of thrust manipulation versus non-thrust manipulation: a randomized clinical trial. Man Ther. 2013 Jun;18(3):191-8. doi: 10.1016/j.math.2012.08.005. Epub 2012 Oct 2.

  PMID: 23040656 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Musculoskeletal Manipulations; Dry Needling

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; Rehabilitation

Study Officials

• Ken Learman, PhD

  Faculty

  PRINCIPAL INVESTIGATOR

• David W Griswold, Doctorate

  Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 9, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 17, 2018

Record last verified: 2018-09

Locations

US (1)