NCT02312895

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

Randomized Controlled Trial Comparing the Use of Dry Needling to Manual Therapy for Patients With Mechanical Low Back Pain.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Youngstown State University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Procedures: Subjects will sign the informed consent prior to any examination procedures. Eligibility assessment will be performed by the treating physical therapist and will include the subject filling out the demographic / health history questionnaire, outcome measures, and a clinical examination. The treating physical therapist will use 2 components of the examination for eligibility criteria into the study. The treating therapist will press on the subject's joints in their back to try to elicit their chief complaint. The treating physical therapist will also press on the soft tissue of the subject's back to check for any symptomatic points. A symptomatic point would include recreation of their chief complaint, tenderness, hypersensitivity, or referred pain. The treating physical therapist will then draw an X on the patient's back where the most symptomatic tissue exists. This point will be used by the data collecting physical therapist in order to collect pain pressure threshold of the area. The data collecting physical therapist will have the subject complete an Oswestry Disability Index(ODI), gather a measure of the pain from the patient ,and the pain pressure threshold. Each subject will then be allocated to either the manual therapy group or the dry needling group. Once a subject is assigned to a group, they will receive either dry needling or manual therapy mobilizations by the treating therapist. Each subject will remain in the assigned group as long as they are continuing in the study up to 3 weeks. In addition to the treatments under investigation, a standardized home exercise program will be assigned to each of the subjects by the treating physical therapist. This program will be given to and reviewed with each subject to ensure they understand the exercises and will perform the exercise program 1x/day for the duration they are under the care of the physical therapist for the study. Subjects will be treated on day 1 of their plan of care and subsequent treatments will occur 2x/week for a total of 3 weeks, unless discharge occurs earlier than the 3 week data point. Early discharge will occur if the subject achieves resolution of symptoms or if they decide they no longer wish to be a research participant. Subsequent sessions will involve the collection of outcome data by the data-collecting therapist followed by treatment performed by the treating physical therapist. No adjustments will be made to the treatment protocol in any of the sessions. Subjects will only be scheduled with and treated by the same treating physical therapist each session. In the event that a treating physical therapist is unable to see a subject participating in the study, the subject will be rescheduled for a different time to receive care.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	Manual therapy	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.
OTHER	Dry needling	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.
OTHER	Home Exercise Program	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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2014-12-09
• Last updated: 2018-09-17

Locations

1 site across 1 country: United States