OsteoarthritisNCT04195464
Effects of Dry Needling on Muscle Function in Patients With Hip Osteoarthritis
A study testing Dry needling in people with Osteoarthritis, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
The aim of this study was to assess the effects of dry needling technique on muscle strength and muscle length in patients with hip osteoarthritis at short term. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- 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
- 11 Dec 2019to 10 Feb 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
- 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
- Fear of needles
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to assess the effects of dry needling technique on muscle strength and muscle length in patients with hip osteoarthritis at short term.
- Conditions
- Osteoarthritis
- Being tested
- Dry needling, Sham dry needling
- Medical subject headings
- Osteoarthritis
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 |
|---|---|---|
| DN | Experimental | Not described Receives: Other: Dry needling |
| Sham-DN | Sham comparator | Not described Receives: Other: Sham dry needling |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
The examiners assess the muscle strength using a hand-held dynamometer (model 01165) for hip internal and external rotation, flexion, extension, abduction and adduction.
Measured: Baseline
muscle strength
The examiners assess the muscle strength using a hand-held dynamometer (model 01165) for hip internal and external rotation, flexion, extension, abduction and adduction.
Measured: up to 3 weeks
Physical function
the examiners assess the physical function using the TImed Up and Go (TUG test) and the 40 meters-self-placed test .
Measured: Baseline
Physical function
the examiners assess the physical function using the TImed Up and Go (TUG test) and the 40 meters-self-placed test .
Measured: up to 3 weeks
Pain intensity
The examiners assess pain intensity after physical function tests using visual analogue scale
Measured: Baseline
Pain intensity
The examiners assess pain intensity after physical function tests using visual analogue scale
Measured: up to 3 weeks
Functional capacity with a validated questionnaire (WOMAC)
The examiners assess pain, stifness and functional capacity using the Western Ontario y McMaster Questionnaire
Measured: Baseline
Functional capacity with a validated questionnaire (WOMAC)
The examiners assess pain, stifness and functional capacity using the Western Ontario y McMaster Questionnaire
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 posted11 Dec 2019
- Study start11 Dec 2019
- Primary completion14 Jan 2020
- Study completion10 Feb 2020
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 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 (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
- NCT04195464
- Sponsor's protocol ID
- Universidad de Valladolid
- Status last verified
- May 2020
- First submitted
- 4 Dec 2019
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ceballos-Laita L, Jimenez-Del-Barrio S, Marin-Zurdo J, Moreno-Calvo A, Marin-Bone J, Albarova-Corral MI, Estebanez-de-Miguel E. Effectiveness of Dry Needling Therapy on Pain, Hip Muscle Strength, and Physical Function in Patients With Hip Osteoarthritis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):959-966. doi: 10.1016/j.apmr.2021.01.077. Epub 2021 Feb 7.
PubMed 33567336
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dry Needling on Muscle Function in Patients With Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT04195464
- Acronym / sponsor ID
- Universidad de Valladolid
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 11 Dec 2019 (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.
The aim of this study was to assess the effects of dry needling technique on muscle strength and muscle length in patients with hip osteoarthritis at short term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DN | Experimental | Other: Dry needling |
| Sham-DN | Sham comparator | Other: Sham dry needling |
| Control | No intervention | – |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not 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 (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
- 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 | DN |
| Sham dry needlingSham Dry needling use a non-penetrating acupuncture needle | Other | Sham-DN |
Primary outcome
muscle strength
Time frame: Baseline
The examiners assess the muscle strength using a hand-held dynamometer (model 01165) for hip internal and external rotation, flexion, extension, abduction and adduction.
muscle strength
Time frame: up to 3 weeks
The examiners assess the muscle strength using a hand-held dynamometer (model 01165) for hip internal and external rotation, flexion, extension, abduction and adduction.
Physical function
Time frame: Baseline
the examiners assess the physical function using the TImed Up and Go (TUG test) and the 40 meters-self-placed test .
Physical function
Time frame: up to 3 weeks
the examiners assess the physical function using the TImed Up and Go (TUG test) and the 40 meters-self-placed test .
Pain intensity
Time frame: Baseline
The examiners assess pain intensity after physical function tests using visual analogue scale
Pain intensity
Time frame: up to 3 weeks
The examiners assess pain intensity after physical function tests using visual analogue scale
Functional capacity with a validated questionnaire (WOMAC)
Time frame: Baseline
The examiners assess pain, stifness and functional capacity using the Western Ontario y McMaster Questionnaire
Functional capacity with a validated questionnaire (WOMAC)
Time frame: Up to 3 weeks
The examiners assess pain, stifness and functional capacity using the Western Ontario y McMaster Questionnaire
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 13 May 2020.
- Derived from this study: PubMed 33567336Ceballos-Laita L, Jimenez-Del-Barrio S, Marin-Zurdo J, Moreno-Calvo A, Marin-Bone J, Albarova-Corral MI, Estebanez-de-Miguel E. Effectiveness of Dry Needling Therapy on Pain, Hip Muscle Strength, and Physical Function in Patients With Hip Osteoarthritis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):959-966. doi: 10.1016/j.apmr.2021.01.077. Epub 2021 Feb 7.
- Individual participant dataSharing planned: Undecided
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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, 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 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 13 May 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. 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?
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 strength (time frame: Baseline). The study lists 8 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 NCT04195464, 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 13 May 2020.