Effects of Dry Needling Technique in Hip Muscles in Subjects With Grade I-III Hip Osteoarthritis

Sponsor
Universidad de Zaragoza (Other)
Overall Status
Unknown status
CT.gov ID
NCT03202056
Collaborator
(none)
45
1
3
12
3.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dry needling
  • Other: Sham Dry needling
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Dry Needling Technique in Hip Muscles in Subjects With Grade I-III Hip Osteoarthritis
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Nov 1, 2018
Anticipated Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dry needling

Dry needling technique in each active myofascial trigger point once per week for 3 weeks.

Other: Dry needling
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.

Sham Comparator: Sham Dry needling

Sham Dry needling technique in each active myofascial trigger point once per week for 3 weeks.

Other: Sham Dry needling
Sham Dry needling use a non-penetrating acupuncture needle

No Intervention: Control

Control group. No intervention.

Outcome Measures

Primary Outcome Measures

  1. Functional Capacity with functional tests [Baseline]

    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

  2. Intensity symptoms [Baseline]

    The investigators measure the intensity of with a visual analogic scale pre-intervention at baseline

  3. Intensity symptoms [through study completion, an average 21 days]

    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)

  4. Functional Capacity with functional tests [through study completion, an average 21 days]

    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

  1. Hip Range of motion [Baseline]

    The investigators measure the hip range of motion with an inclinometer at baseline

  2. Hip Range of motion [through study completion, an average 21 days]

    The investigators measure the hip range of motion with an inclinometer at the end of the intervention (through study completion, an average 21 days)

  3. Muscular strength [Baseline]

    The investigators measure the hip strength with a hand held dynamometer (Lafayette) at baseline

  4. Muscular strength [through study completion, an average 21 days]

    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)

  5. Muscular length [Baseline]

    The investigators measure the muscular length with Passive Knee Extension test, ELY test, and modified Ober test at baseline

  6. Muscular length [through study completion, an average 21 days]

    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)

  7. Pain threshold [Baseline]

    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

  8. Pain threshold [through study completion, an average 21 days]

    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)

  9. Anxiety and depression with a validated questionnaire (HADS) [Baseline]

    The investigators measure the anxiety and depression with HADS questionnaire at baseline

  10. Anxiety and depression with a validated questionnaire (HADS) [through study completion, an average 21 days]

    The investigators measure the anxiety and depression with HADS questionnaire at the end of the intervention (through study completion, an average 21 days)

  11. Functional capacity with a validated questionnaire (WOMAC) [Baseline]

    The investigator measure the functional capacity with WOMAC questionnaire at baseline

  12. Functional capacity with a validated questionnaire (WOMAC) [through study completion, an average 21 days]

    The investigator measure the functional capacity with WOMAC questionnaire at the end of the intervention (through study completion, an average 21 days)

  13. Gait in treadmill [Baseline]

    The investigator measure gait pattern in treadmill using wearable inertial sensors to track body kinematics during gait

  14. Gait in treadmill [through study completion]

    The investigator measure gait pattern in treadmill using wearable inertial sensors to track body kinematics during gait

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Luis Ceballos Laita Zaragoza Spain 50008

Sponsors and Collaborators

  • Universidad de Zaragoza

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luis Ceballos Laita, Principal Investigator, Universidad de Zaragoza
ClinicalTrials.gov Identifier:
NCT03202056
Other Study ID Numbers:
  • C.I.PI17/0182
First Posted:
Jun 28, 2017
Last Update Posted:
Oct 15, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Luis Ceballos Laita, Principal Investigator, Universidad de Zaragoza
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2018