Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2026-04-07 @ 1:57 PM
Study NCT ID:
NCT02312895
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2014-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Dry Needling to Manual Therapy for Patients With Mechanical Low Back Pain
Sponsor:
Youngstown State University
Organization:
Study Overview
Official Title:
Randomized Controlled Trial Comparing the Use of Dry Needling to Manual Therapy for Patients With Mechanical Low Back Pain.
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: