Effects of Dry Needling Technique in Hip Muscles in Subjects With Grade I-III Hip Osteoarthritis
Primary Purpose
Hip Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Sham Dry needling
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring hip osteoarthritis, physiotherapy, manual therapy
Eligibility Criteria
Inclusion Criteria:
- Diagnosed medically with a X-Ray test
- American College of Rheumatology Criteria
Exclusion Criteria:
- Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic disease, congenital diseases etc.
- Vascular or neurological disease.
- Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs
- Grade IV in Kellgren and Laurence Scale
- Fear of needles
Sites / Locations
- Luis Ceballos Laita
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
No Intervention
Arm Label
Dry needling
Sham Dry needling
Control
Arm Description
Dry needling technique in each active myofascial trigger point once per week for 3 weeks.
Sham Dry needling technique in each active myofascial trigger point once per week for 3 weeks.
Control group. No intervention.
Outcomes
Primary Outcome Measures
Functional Capacity with functional tests
The investigators measure the functional capacity with functional test: "test Up and Go" (TUG), "20 and 40 meters self-placed" and "30 seconds-chair stand" at baseline
Intensity symptoms
The investigators measure the intensity of with a visual analogic scale pre-intervention at baseline
Intensity symptoms
The investigators measure the intensity of with a visual analogic scale at the end of the intervention (3 weeks after baseline the investigators measure the intensity of symptoms through study completion, an average 21 days)
Functional Capacity with functional tests
The investigator measure the functional capacity with functional test: "Test Up and Go" (TUG test), "20 and 40 meters self-placed" and "30 seconds-chair and stand" at the end of the intervention (through study completion, an average 21 days).
Secondary Outcome Measures
Hip Range of motion
The investigators measure the hip range of motion with an inclinometer at baseline
Hip Range of motion
The investigators measure the hip range of motion with an inclinometer at the end of the intervention (through study completion, an average 21 days)
Muscular strength
The investigators measure the hip strength with a hand held dynamometer (Lafayette) at baseline
Muscular strength
The investigators measure the hip strength with a hand held dynamometer (Lafayette) at the end of the intervention (through study completion, an average 21 days)
Muscular length
The investigators measure the muscular length with Passive Knee Extension test, ELY test, and modified Ober test at baseline
Muscular length
The investigators measure the muscular length with Passive Knee Extension test, ELY test, and modified Ober test at the end of the intervention (through study completion, an average 21 days)
Pain threshold
The investigators measure the pain threshold with a digital algometer in myofascial trigger points of the hip muscles, and also other bone areas to discriminate a central sensitization at baseline
Pain threshold
The investigators measure the pain threshold with a digital algometer in myofascial trigger points of the hip muscles, and also other bone areas to discriminate a central sensitization at the end of the intervention (through study completion, an average 21 days)
Anxiety and depression with a validated questionnaire (HADS)
The investigators measure the anxiety and depression with HADS questionnaire at baseline
Anxiety and depression with a validated questionnaire (HADS)
The investigators measure the anxiety and depression with HADS questionnaire at the end of the intervention (through study completion, an average 21 days)
Functional capacity with a validated questionnaire (WOMAC)
The investigator measure the functional capacity with WOMAC questionnaire at baseline
Functional capacity with a validated questionnaire (WOMAC)
The investigator measure the functional capacity with WOMAC questionnaire at the end of the intervention (through study completion, an average 21 days)
Gait in treadmill
The investigator measure gait pattern in treadmill using wearable inertial sensors to track body kinematics during gait
Gait in treadmill
The investigator measure gait pattern in treadmill using wearable inertial sensors to track body kinematics during gait
Full Information
NCT ID
NCT03202056
First Posted
June 13, 2017
Last Updated
October 10, 2018
Sponsor
Universidad de Zaragoza
1. Study Identification
Unique Protocol Identification Number
NCT03202056
Brief Title
Effects of Dry Needling Technique in Hip Muscles in Subjects With Grade I-III Hip Osteoarthritis
Official Title
Effects of Dry Needling Technique in Hip Muscles in Subjects With Grade I-III Hip Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Dry needling is a new treatment technique, addressed to mechanical pain of the neuromusculoskeletal system. Recent investigations has developed new hypothesis about the etiology of the osteoarthritis and could be in relation to musculoskeletal disorders, but there is no published studies evaluating the results of this technique in hip osteoarthritis patients.
The objective of this trial is to evaluate if dry needling is more effective in symptoms, function, range of motion, strength, muscular length, pain threshold and compared to sham dry needling and control.
For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of hip osteoarthritis Grade I-III by Scale of Kellgren and Lawrence.
Patients included are randomized into 3 groups one receive Dry needling, other sham dry needling and the other is a control. Groups receive 3 treatment sessions.
The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session. Patients who participated in sham dry needling or control group, when the intervention finish the investigators will be given the opportunity to receive the actual technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
hip osteoarthritis, physiotherapy, manual therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dry needling
Arm Type
Experimental
Arm Description
Dry needling technique in each active myofascial trigger point once per week for 3 weeks.
Arm Title
Sham Dry needling
Arm Type
Sham Comparator
Arm Description
Sham Dry needling technique in each active myofascial trigger point once per week for 3 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group. No intervention.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
Dry needling is a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments.
Intervention Type
Other
Intervention Name(s)
Sham Dry needling
Intervention Description
Sham Dry needling use a non-penetrating acupuncture needle
Primary Outcome Measure Information:
Title
Functional Capacity with functional tests
Description
The investigators measure the functional capacity with functional test: "test Up and Go" (TUG), "20 and 40 meters self-placed" and "30 seconds-chair stand" at baseline
Time Frame
Baseline
Title
Intensity symptoms
Description
The investigators measure the intensity of with a visual analogic scale pre-intervention at baseline
Time Frame
Baseline
Title
Intensity symptoms
Description
The investigators measure the intensity of with a visual analogic scale at the end of the intervention (3 weeks after baseline the investigators measure the intensity of symptoms through study completion, an average 21 days)
Time Frame
through study completion, an average 21 days
Title
Functional Capacity with functional tests
Description
The investigator measure the functional capacity with functional test: "Test Up and Go" (TUG test), "20 and 40 meters self-placed" and "30 seconds-chair and stand" at the end of the intervention (through study completion, an average 21 days).
Time Frame
through study completion, an average 21 days
Secondary Outcome Measure Information:
Title
Hip Range of motion
Description
The investigators measure the hip range of motion with an inclinometer at baseline
Time Frame
Baseline
Title
Hip Range of motion
Description
The investigators measure the hip range of motion with an inclinometer at the end of the intervention (through study completion, an average 21 days)
Time Frame
through study completion, an average 21 days
Title
Muscular strength
Description
The investigators measure the hip strength with a hand held dynamometer (Lafayette) at baseline
Time Frame
Baseline
Title
Muscular strength
Description
The investigators measure the hip strength with a hand held dynamometer (Lafayette) at the end of the intervention (through study completion, an average 21 days)
Time Frame
through study completion, an average 21 days
Title
Muscular length
Description
The investigators measure the muscular length with Passive Knee Extension test, ELY test, and modified Ober test at baseline
Time Frame
Baseline
Title
Muscular length
Description
The investigators measure the muscular length with Passive Knee Extension test, ELY test, and modified Ober test at the end of the intervention (through study completion, an average 21 days)
Time Frame
through study completion, an average 21 days
Title
Pain threshold
Description
The investigators measure the pain threshold with a digital algometer in myofascial trigger points of the hip muscles, and also other bone areas to discriminate a central sensitization at baseline
Time Frame
Baseline
Title
Pain threshold
Description
The investigators measure the pain threshold with a digital algometer in myofascial trigger points of the hip muscles, and also other bone areas to discriminate a central sensitization at the end of the intervention (through study completion, an average 21 days)
Time Frame
through study completion, an average 21 days
Title
Anxiety and depression with a validated questionnaire (HADS)
Description
The investigators measure the anxiety and depression with HADS questionnaire at baseline
Time Frame
Baseline
Title
Anxiety and depression with a validated questionnaire (HADS)
Description
The investigators measure the anxiety and depression with HADS questionnaire at the end of the intervention (through study completion, an average 21 days)
Time Frame
through study completion, an average 21 days
Title
Functional capacity with a validated questionnaire (WOMAC)
Description
The investigator measure the functional capacity with WOMAC questionnaire at baseline
Time Frame
Baseline
Title
Functional capacity with a validated questionnaire (WOMAC)
Description
The investigator measure the functional capacity with WOMAC questionnaire at the end of the intervention (through study completion, an average 21 days)
Time Frame
through study completion, an average 21 days
Title
Gait in treadmill
Description
The investigator measure gait pattern in treadmill using wearable inertial sensors to track body kinematics during gait
Time Frame
Baseline
Title
Gait in treadmill
Description
The investigator measure gait pattern in treadmill using wearable inertial sensors to track body kinematics during gait
Time Frame
through study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosed medically with a X-Ray test
American College of Rheumatology Criteria
Exclusion Criteria:
Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic disease, congenital diseases etc.
Vascular or neurological disease.
Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs
Grade IV in Kellgren and Laurence Scale
Fear of needles
Facility Information:
Facility Name
Luis Ceballos Laita
City
Zaragoza
ZIP/Postal Code
50008
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The patient data were confidential and were assigned a number to each patient to maintain confidentiality
Citations:
PubMed Identifier
31352178
Citation
Ceballos-Laita L, Jimenez-Del-Barrio S, Marin-Zurdo J, Moreno-Calvo A, Marin-Bone J, Albarova-Corral MI, Estebanez-de-Miguel E. Effects of dry needling in HIP muscles in patients with HIP osteoarthritis: A randomized controlled trial. Musculoskelet Sci Pract. 2019 Oct;43:76-82. doi: 10.1016/j.msksp.2019.07.006. Epub 2019 Jul 24.
Results Reference
derived
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Effects of Dry Needling Technique in Hip Muscles in Subjects With Grade I-III Hip Osteoarthritis
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