Knee OsteoarthritisNCT02698072
Improvement in Pain and Function Following a Physiotherapy Program in Older Adults With Knee Osteoarthritis
A study testing Therapeutic exercise and Dry needling in people with Knee Osteoarthritis, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
This study evaluates the combination of a therapeutic exercise program and dry needling in the treatment of knee osteoarthritis in older adults. Half of participants will receive therapeutic exercise program and dry needling in combination, while the other half will receive the same therapeutic exercise program and… Read more about this study
- Who is it for?
- Ages 62 to 100 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Therapeutic exercise and Dry needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2016to Jun 2017
- 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 62 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 62 years and older.
- Unilateral or bilateral disfunction and/or knee pain.
- Primary knee ostearthritis fulfilling the American College of Rheumatology criteria for clinical and radiographic diagnostic.
- At least 1 pain point elicited by palpation ipsilateral to the painful knee situated in a taut band of a skeletal muscle of the lower limbs, which usually have referred pain.
Who cannot join
- Prior diagnoses or prescriptions in the medical record for myopathy or lumbo-sacral neuropathy.
- Previous knee or hip joint replacement surgery of the affected joint.
- Any other surgical procedure of the lower limbs in the previous 6 months.
- Rheumatoid arthritis.
- Initiation of opioid analgesia or cortico-steroid or analgesic injection intervention for hip or knee pain within the previous 30 days.
- Alcohol or drugs consumption.
Show all 13Show fewer
- Uncontrolled hypertension or moderate to high risk for cardiac complications during exercise.
- Conservative or invasive physical therapy (previous 6 months or during follow-up).
- Taking antiaggregant or anticoagulant medications.
- Physical impairments unrelated to the hip or knee preventing safe participation in exercise, walking or stationary cycling, such as: vision problems that affect mobility, body weight greater than 155 kg, neurogenic disorder, primary or significantly limiting back pain, advanced osteoporosis, or inability to walk 10 metres without an assistive device.
- Inability to comprehend and complete study assessments or comply with study instructions.
- Stated inability to attend or complete the proposed course of intervention and follow-up schedule.
- Fibromyalgia syndrome or other altered affective/cognitive modulation processes of pain perception. .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement in Pain and Function Following a Therapeutic Exercise Program and Dry Needling in Older Adults With Knee Osteoarthritis: A Randomized Double-blind Multicenter Controlled Clinical Trial
This study evaluates the combination of a therapeutic exercise program and dry needling in the treatment of knee osteoarthritis in older adults. Half of participants will receive therapeutic exercise program and dry needling in combination, while the other half will receive the same therapeutic exercise program and sham dry needling.
Read the detailed description
Therapeutic exercise and dry needling each relieve pain and improve function, but they are different treatment tools.
Therapeutic exercise takes a multitude of forms and results in numerous systemic and local effects, some of which have been investigate among people with knee osteoarthritis. Therapeutic exercise covers a range of targeted physical activities that directly aim to improve muscle strength, neuromotor control, joint range of motion and aerobic fitness. One of the main aims of this therapeutic approach is to improve muscle strength, given that weakness is common in knee osteoarthritis. Enhanced strength of the lower limb may lessen internal knee forces, reduce pain and improve physical function.
Primary knee osteoarthritis provokes pain and disfunction is thought mediated by joint damage and changes in joint homeostasis. Recently, investigations focused in impaired neuromuscular system as a contribution to the above mentioned symptoms in the knee osteoarthritis syndrome explore the use of dry needling. Dry needling is a therapeutic approach for decreasing pain and improve function with high recommended evidence (grade A) effectiveness for upper-quarter myofascial pain, but poorly understood in knee osteoarthritis patients.
- Conditions
- Knee Osteoarthritis
- Being tested
- Therapeutic exercise, Dry needling, Sham dry needling
- Keywords
- Stiffness, Pain, Disfunction
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exerciseOther
20-25 minutes aerobic exercise, 20-25 minutes strength exercise and 10-15 minutes stretch exercise.
Dry needlingDevice
Dry needling needle AGUPUNT®
Sham dry needlingDevice
Sham dry needling DONGBANG-ACUPRIME®
| Study group | Role | What they receive |
|---|---|---|
| Exercise and dry needling | Experimental | 24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min).
6 dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using Hong's fast-in and fast-out technique with multiple rapid needle insertion. Receives: Other: Therapeutic exercise; Device: Dry needling |
| Exercise and sham dry needling | Active comparator | 24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min).
6 sham dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using a park sham device consists of a base with a hole in the centre and sticky tape on the bottom. From the top of the base extends a double tube, continuing the central hole in the base. Receives: Other: Therapeutic exercise; Device: Sham dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Osteoarthritis Index (WOMAC) change assessment.
The disease-specific questionnaire WOMAC is the most widely used instrument created and validated to evaluate both the symptomatology and function on osteoarthritis of the hip or knee.
Measured: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
Secondary outcomes (5)
Numeric Pain Rating Scale (NPRS)
Pain intensity will be assessed using a NPRS of 11 points (from 0, no pain, to 10, maximum pain). The patient determined their subjective pain intensity of the painful knee by pointing with 1 of their fingers to mark the level of pain on the scale. .
Measured: Base line, through study completion (3 months); ; and 3, 6 and 12 months follow-up
Barthel Index
The Barthel Index is considered to be the best of the activities of daily living measurement scales. The modified scoring of the Barthel Index by Shah achieved greater sensitivity and improved reliability than the original version, without causing additional difficulty or affecting the implementation time.
Measured: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
The Timed Up & Go Test
The patient is asked to perform the rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return, return and sit down again. The score given is the time taken in seconds to complete the test.
Measured: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
Mini-Mental State Examination (MMSE)
It's a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment and to screen for dementia.
Measured: Base line and 12 months follow-up
EuroQol-5
It provides a simple descriptive profile and a single index value for health status through rating of 5 items.
Measured: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study start15 Mar 2016
- Primary completion16 Jun 2016
- Study completionJun 2017
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 Knee 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
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Colegio de Fisioterapeutas de la Comunidad de Madrid
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- Eleuterio Atanasio Sánchez Romero, PT, MSc, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02698072
- Sponsor's protocol ID
- 13/2015
- Status last verified
- Dec 2017
- First submitted
- 4 Jan 2016
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sanchez Romero EA, Fernandez-Carnero J, Calvo-Lobo C, Ochoa Saez V, Burgos Caballero V, Pecos-Martin D. Is a Combination of Exercise and Dry Needling Effective for Knee OA? Pain Med. 2020 Feb 1;21(2):349-363. doi: 10.1093/pm/pnz036.
PubMed 30889250
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Pain and Function Following a Therapeutic Exercise Program and Dry Needling in Older Adults With Knee Osteoarthritis: A Randomized Double-blind Multicenter Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02698072
- Acronym / sponsor ID
- 13/2015
- Conditions
- Knee Osteoarthritis
- Keywords
- Stiffness, Pain, Disfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Collaborators
- Colegio de Fisioterapeutas de la Comunidad de Madrid
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 16 Jun 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 3 Mar 2016 (estimated)
- 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.
This study evaluates the combination of a therapeutic exercise program and dry needling in the treatment of knee osteoarthritis in older adults. Half of participants will receive therapeutic exercise program and dry needling in combination, while the other half will receive the same therapeutic exercise program and sham dry needling.
Detailed description
Therapeutic exercise and dry needling each relieve pain and improve function, but they are different treatment tools.
Therapeutic exercise takes a multitude of forms and results in numerous systemic and local effects, some of which have been investigate among people with knee osteoarthritis. Therapeutic exercise covers a range of targeted physical activities that directly aim to improve muscle strength, neuromotor control, joint range of motion and aerobic fitness. One of the main aims of this therapeutic approach is to improve muscle strength, given that weakness is common in knee osteoarthritis. Enhanced strength of the lower limb may lessen internal knee forces, reduce pain and improve physical function.
Primary knee osteoarthritis provokes pain and disfunction is thought mediated by joint damage and changes in joint homeostasis. Recently, investigations focused in impaired neuromuscular system as a contribution to the above mentioned symptoms in the knee osteoarthritis syndrome explore the use of dry needling. Dry needling is a therapeutic approach for decreasing pain and improve function with high recommended evidence (grade A) effectiveness for upper-quarter myofascial pain, but poorly understood in knee osteoarthritis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and dry needling | Experimental | Other: Therapeutic exercise, Device: Dry needling24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min). 6 dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using Hong's fast-in and fast-out technique with multiple rapid needle insertion. |
| Exercise and sham dry needling | Active comparator | Other: Therapeutic exercise, Device: Sham dry needling24 therapeutic exercise sessions (twice a week) of a land-based therapeutic exercise program consisting of aerobic exercise (20-25 min warm-up), lower limbs muscle strengthening (20-25 min) and lower limbs muscles stretching (10-15 min). 6 sham dry needling sessions (once a week) at all the pain points of the involved symptomatic lower limb/s using a park sham device consists of a base with a hole in the centre and sticky tape on the bottom. From the top of the base extends a double tube, continuing the central hole in the base. |
Who may qualify
- Ages
- 62 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged 62 years and older.
- Unilateral or bilateral disfunction and/or knee pain.
- Primary knee ostearthritis fulfilling the American College of Rheumatology criteria for clinical and radiographic diagnostic.
- At least 1 pain point elicited by palpation ipsilateral to the painful knee situated in a taut band of a skeletal muscle of the lower limbs, which usually have referred pain.
Key exclusion criteria (13 listed)
- Prior diagnoses or prescriptions in the medical record for myopathy or lumbo-sacral neuropathy.
- Previous knee or hip joint replacement surgery of the affected joint.
- Any other surgical procedure of the lower limbs in the previous 6 months.
- Rheumatoid arthritis.
- Initiation of opioid analgesia or cortico-steroid or analgesic injection intervention for hip or knee pain within the previous 30 days.
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 |
|---|---|---|
| Therapeutic exercise20-25 minutes aerobic exercise, 20-25 minutes strength exercise and 10-15 minutes stretch exercise. | Other | Exercise and dry needling, Exercise and sham dry needling |
| Dry needlingDry needling needle AGUPUNT® | Device | Exercise and dry needling |
| Sham dry needlingSham dry needling DONGBANG-ACUPRIME® | Device | Exercise and sham dry needling |
Primary outcome
Western Ontario and McMaster Osteoarthritis Index (WOMAC) change assessment.
Time frame: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
The disease-specific questionnaire WOMAC is the most widely used instrument created and validated to evaluate both the symptomatology and function on osteoarthritis of the hip or knee.
5 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: Base line, through study completion (3 months); ; and 3, 6 and 12 months follow-up
Barthel Index
Time frame: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
The Timed Up & Go Test
Time frame: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
Mini-Mental State Examination (MMSE)
Time frame: Base line and 12 months follow-up
EuroQol-5
Time frame: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up
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 12 Dec 2017.
- Derived from this study: PubMed 30889250Sanchez Romero EA, Fernandez-Carnero J, Calvo-Lobo C, Ochoa Saez V, Burgos Caballero V, Pecos-Martin D. Is a Combination of Exercise and Dry Needling Effective for Knee OA? Pain Med. 2020 Feb 1;21(2):349-363. doi: 10.1093/pm/pnz036.
- website of the University Rey Juan CarlosLink provided by the sponsor.
- 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.
Eleuterio Atanasio Sánchez Romero, PT, MSc principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise and Dry needling in people with Knee Osteoarthritis, run by Universidad Rey Juan Carlos 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 4 inclusion and 13 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 12 Dec 2017. 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?
Western Ontario and McMaster Osteoarthritis Index (WOMAC) change assessment. (time frame: Base line, through study completion (3 months); and 3, 6 and 12 months follow-up). 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 NCT02698072, 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 12 Dec 2017.