Osteoarthritis, HipNCT04400825
Dry Needling Versus Stretching for Muscle Extensibility
A study testing Dry needling in people with Osteoarthritis, Hip, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Currently several authors have shown the presence of active myofascial trigger points (MTrP) in the muscles surrounding the hip joint that reproduce the symptoms of the patients with hip OA. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2020to 19 Jul 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral hip OA diagnosed medically with a X-Ray tess and following the 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
- DN contraindications or fear of needles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Dry Needling and Stretching for the Management of Muscle Extensibility in Patients With Hip Osteoarthritis: A Randomized Clinical Trial
Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Currently several authors have shown the presence of active myofascial trigger points (MTrP) in the muscles surrounding the hip joint that reproduce the symptoms of the patients with hip OA.
Despite of the beneficial effects that have shown may conservative non-pharmacological treatments, there is a lack of studies evaluating the effects of the conservative treatments on muscle extensibility.
According to the new paradigm about the presence of MTrPs, the investigators decided to conduct a randomized clinical trial to compare the effects of DN intervention and stretching protocol on muscle extensibility in patients with hip OA.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Dry needling
- Keywords
- physiotherapy, stretching, dry needling
- 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 of the active MTrPs following the technique described by Hong et al (1994,1995)
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Dry needling of 3 active MTrPs at most. Receives: Other: Dry needling |
| Stretching | Active comparator | Stretching of the main hip flexors (rectus femoris, iliopsoas and tensor fasciae latae) Receives: Other: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle extensibility
the examiners assess the muscle extensibility using an inclinomenter
Measured: Baseline
muscle extensibility
the examiners assess the muscle extensibility using an inclinomenter
Measured: up to 3 weeks
Secondary outcomes (2)
Stiffness
the examiners assess the stiffness using the WOMAC stiffness subscale
Measured: Baseline
Stiffness
the examiners assess the stiffness using the WOMAC stiffness subscale
Measured: up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 May 2020
- Primary completion19 Jul 2020
- Study completion19 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies 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
- Model description
- randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
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
- NCT04400825
- Sponsor's protocol ID
- CEIm1955
- Status last verified
- Nov 2020
- First submitted
- 19 May 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Dry Needling and Stretching for the Management of Muscle Extensibility in Patients With Hip Osteoarthritis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04400825
- Acronym / sponsor ID
- CEIm1955
- Conditions
- Osteoarthritis, Hip
- Keywords
- physiotherapy, stretching, dry needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 19 Jul 2020 (actual)
- Study completion
- 19 Jul 2020 (actual)
- First posted
- 26 May 2020 (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.
Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Currently several authors have shown the presence of active myofascial trigger points (MTrP) in the muscles surrounding the hip joint that reproduce the symptoms of the patients with hip OA.
Despite of the beneficial effects that have shown may conservative non-pharmacological treatments, there is a lack of studies evaluating the effects of the conservative treatments on muscle extensibility.
According to the new paradigm about the presence of MTrPs, the investigators decided to conduct a randomized clinical trial to compare the effects of DN intervention and stretching protocol on muscle extensibility in patients with hip OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry needlingDry needling of 3 active MTrPs at most. |
| Stretching | Active comparator | Other: Dry needlingStretching of the main hip flexors (rectus femoris, iliopsoas and tensor fasciae latae) |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- unilateral hip OA diagnosed medically with a X-Ray tess and following the American College of Rheumatology Criteria
Key exclusion criteria (4 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
- DN contraindications or 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 of the active MTrPs following the technique described by Hong et al (1994,1995) | Other | Dry needling, Stretching |
Primary outcome
muscle extensibility
Time frame: Baseline
the examiners assess the muscle extensibility using an inclinomenter
muscle extensibility
Time frame: up to 3 weeks
the examiners assess the muscle extensibility using an inclinomenter
2 secondary outcomes
Stiffness
Time frame: Baseline
Stiffness
Time frame: up to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No
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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 Osteoarthritis, Hip, 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 3 Nov 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
muscle extensibility (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2020.