Hip OsteoarthritisNCT03202056
Effects of Dry Needling Technique in Hip Muscles in Subjects With Grade I-III Hip Osteoarthritis
A study testing Dry needling in people with Hip Osteoarthritis, run by Universidad de Zaragoza at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed medically with a X-Ray test
- American College of Rheumatology Criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Hip Osteoarthritis
- Being tested
- Dry needling, Sham Dry needling
- Keywords
- hip osteoarthritis, physiotherapy, manual therapy
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
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 Dry needlingOther
Sham Dry needling use a non-penetrating acupuncture needle
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Dry needling technique in each active myofascial trigger point once per week for 3 weeks. Receives: Other: Dry needling |
| Sham Dry needling | Sham comparator | Sham Dry needling technique in each active myofascial trigger point once per week for 3 weeks. Receives: Other: Sham Dry needling |
| Control | No intervention | Control group. No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Intensity symptoms
The investigators measure the intensity of with a visual analogic scale pre-intervention at baseline
Measured: 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)
Measured: 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).
Measured: through study completion, an average 21 days
Secondary outcomes (14)
Hip Range of motion
The investigators measure the hip range of motion with an inclinometer at baseline
Measured: 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)
Measured: through study completion, an average 21 days
Muscular strength
The investigators measure the hip strength with a hand held dynamometer (Lafayette) at baseline
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: Baseline
Gait in treadmill
The investigator measure gait pattern in treadmill using wearable inertial sensors to track body kinematics during gait
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Jan 2018
- Primary completionNov 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Ceballos Laita, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202056
- Sponsor's protocol ID
- C.I.PI17/0182
- Status last verified
- Oct 2018
- First submitted
- 13 Jun 2017
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patient data were confidential and were assigned a number to each patient to maintain confidentiality
Publications
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.
PubMed 31352178
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling Technique in Hip Muscles in Subjects With Grade I-III Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT03202056
- Acronym / sponsor ID
- C.I.PI17/0182
- Conditions
- Hip Osteoarthritis
- Keywords
- hip osteoarthritis, physiotherapy, manual therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry needlingDry needling technique in each active myofascial trigger point once per week for 3 weeks. |
| Sham Dry needling | Sham comparator | Other: Sham Dry needlingSham Dry needling technique in each active myofascial trigger point once per week for 3 weeks. |
| Control | No intervention | –Control group. No intervention. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed medically with a X-Ray test
- American College of Rheumatology Criteria
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry needlingDry 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. | Other | Dry needling |
| Sham Dry needlingSham Dry needling use a non-penetrating acupuncture needle | Other | Sham Dry needling |
Primary outcome
Functional Capacity with functional tests
Time frame: 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
Intensity symptoms
Time frame: Baseline
The investigators measure the intensity of with a visual analogic scale pre-intervention at baseline
Intensity symptoms
Time frame: 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)
Functional Capacity with functional tests
Time frame: 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).
14 secondary outcomes
Hip Range of motion
Time frame: Baseline
Hip Range of motion
Time frame: through study completion, an average 21 days
Muscular strength
Time frame: Baseline
Muscular strength
Time frame: through study completion, an average 21 days
Muscular length
Time frame: Baseline
Muscular length
Time frame: through study completion, an average 21 days
Pain threshold
Time frame: Baseline
Pain threshold
Time frame: through study completion, an average 21 days
Anxiety and depression with a validated questionnaire (HADS)
Time frame: Baseline
Anxiety and depression with a validated questionnaire (HADS)
Time frame: through study completion, an average 21 days
Functional capacity with a validated questionnaire (WOMAC)
Time frame: Baseline
Functional capacity with a validated questionnaire (WOMAC)
Time frame: through study completion, an average 21 days
Gait in treadmill
Time frame: Baseline
Gait in treadmill
Time frame: through study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 31352178Ceballos-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.
- Individual participant dataSharing planned: No. The patient data were confidential and were assigned a number to each patient to maintain confidentiality
Related trials for Hip Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling in people with Hip Osteoarthritis, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity with functional tests (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03202056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.