Lateral EpicondylitisNCT02321696
Physiotherapy or Acupuncture for Lateral Epicondylitis
A study testing Acupuncture, Physiotherapy and eccentric exercise and Watchful waiting and eccentric exercise in people with Lateral Epicondylitis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Work-related upper extremity disorders are common problems in working populations in western countries. Lateral epicondylitis (LE) or tennis elbow is the most frequent type of soft tissue syndrome of the elbow, with an annual incidence of four to seven cases per 1000 patients in general practice, and as high as 15 %… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Acupuncture, Physiotherapy and eccentric exercise and Watchful waiting and eccentric exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2015to Aug 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 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lateral epicondylitis LE (duration > 2 weeks)
- Unilateral localization
- Individuals with average pain of NRS 4 or higher during the last week prior to screening
- Aged between 18 and 67 years
- Written informed consent
Who cannot join
- Corticosteroid injections during the last 4 weeks
- Diseases of the central or peripheral nervous system
- Inflammatory rheumatic diseases
- Radio-ulna or radio humeral osteoarthritis
- Unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparative Effect of Physiotherapy or Acupuncture Treatment of Lateral Epicondylitis; a Randomized Controlled Pilot Trial
Work-related upper extremity disorders are common problems in working populations in western countries. Lateral epicondylitis (LE) or tennis elbow is the most frequent type of soft tissue syndrome of the elbow, with an annual incidence of four to seven cases per 1000 patients in general practice, and as high as 15 % of workers in highly repetitive hand task industries.
LE is a painful condition, leading to loss of function of the affected limb. Therefore it can have a major impact on the patient's work and personal life. If untreated, it persists for an average of six to 24 months and associated with significant sickness absence in 5 % of affected working-aged adults. The cost is therefore high, both in terms of loss of productivity and health care utilization.
Read more
Many treatments have been advocated in the management of LE, possibly implying that much is unknown about its etiology and how it best should be treated. Systematic reviews have failed to draw any firm conclusions as to what treatment is most effective in managing this condition.
Over the past 10 years acupuncture has gained wider acceptance for treating pain, by both clinicians and consumers of health, and there is some evidence suggesting that acupuncture treatment is effective in of acute symptoms in LE. A recent study supports that also elbow manipulation have a short-term relief of acute symptoms in LE, especially when combined with eccentric exercise. Our study will therefore explore the clinical effectiveness of physiotherapy versus acupuncture treatment of LE, compared with watchful waiting.
Read the detailed description
The study design is three armed and randomized, single blinded. The study aims, in a pilot stydy, to test if physiotherapy or acupuncture treatment of lateral epicondylitis, compared with watchful waiting, is useful means in pain relief for patients with lateral epicondylitis.
- Conditions
- Lateral Epicondylitis
- Being tested
- Acupuncture, Physiotherapy and eccentric exercise, Watchful waiting and eccentric exercise, eccentric exercise
- Keywords
- physiotherapy, manual therapy, acupuncture, eccentric exercise
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Physiotherapy and eccentric exerciseOther
Watchful waiting and eccentric exerciseOther
eccentric exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture and eccentric exercise | Experimental | Treatment will be performed according to traditional Chinese methods (STRICTA: Standards for reporting interventions in controlled trials of acupunc-ture). Therapists will select points frequently recommended for the treatment of LE. As local point, LI11 and LI10 over the muscular origin of the lateral extensor group of the forearm will be used, and LU5 in the cubical region. LI4 and TE5 will be regional points for pain therapy in the upper limb, GB34 will be used as a distal point for treatment of tendinosis in general, and ST36 for treatment of pain. Needles will be inserted down to the musculature and obtaining De Qi sensation and will remain in situ for 20 min. All patients will receive four treatment sessions; this may be extended to eight depending on patient's pain report and the therapists' clinical evaluation. Maximum treatment period is 4 weeks. Patients will also be instructed in eccentric strength exercises for daily home training from enrolment and 12 weeks forward. Receives: Device: Acupuncture; Other: eccentric exercise |
| Physiotherapy and eccentric exercise | Experimental | Manual techniques as gliding mobilization of elbow, therapists are spezialised in manual therapy. At least four treatment sessions will be performed, but depending on the patient's perceived intensity of pain and the therapists' clinical evaluation, a maximum of eight treatment session can be given. All treatment session will be performed during a period of maximum 4 weeks.
In addition, patients will be instructed in eccentric strength exercises for daily home training from enrolment and 12 weeks forward. Receives: Other: Physiotherapy and eccentric exercise |
| Watchful waiting and eccentric exercise | Active comparator | Patients will be instructed in eccentric strength exercises for daily home training from enrolment and 12 weeks forward. Receives: Other: Watchful waiting and eccentric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elbow pain on Numeric Rating Scale (0-10)
present, worst and lesser pain during the last week, an average score will be calculated
Measured: 12 weeks and 1 year
Secondary outcomes (6)
The disabilities of the arm shoulder and hand (quick-DASH)
Functional capacity of elbow and arm
Measured: 12 weeks and 1 year
Quality of life by EQ-5D
Quality of life
Measured: 12 weeks and 1 year
Sick listing
Number of days patients are sich listed during the 12 week study period
Measured: 12 weeks and 1 year
Patients satisfaction; global perceived effect and satistfaction with treatment
Measured: 12 weeks and 1 year
Use of analgesics
Measured: 12 weeks and 1 year
Number of treatment sessions
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionAug 2017
- Study completionAug 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 Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Kjersti Storheim, Oslo University Hospital
- Investigators
- Astrid Wahl, PhD, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321696
- Sponsor's protocol ID
- 2014/1520
- Status last verified
- Dec 2017
- First submitted
- 17 Dec 2014
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bostrom K, Maehlum S, Cvancarova Smastuen M, Storheim K. Clinical comparative effectiveness of acupuncture versus manual therapy treatment of lateral epicondylitis: feasibility randomized clinical trial. Pilot Feasibility Stud. 2019 Sep 7;5:110. doi: 10.1186/s40814-019-0490-x. eCollection 2019.
PubMed 31516727
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparative Effect of Physiotherapy or Acupuncture Treatment of Lateral Epicondylitis; a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT02321696
- Acronym / sponsor ID
- 2014/1520
- Conditions
- Lateral Epicondylitis
- Keywords
- physiotherapy, manual therapy, acupuncture, eccentric exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Feb 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Dec 2014 (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.
Work-related upper extremity disorders are common problems in working populations in western countries. Lateral epicondylitis (LE) or tennis elbow is the most frequent type of soft tissue syndrome of the elbow, with an annual incidence of four to seven cases per 1000 patients in general practice, and as high as 15 % of workers in highly repetitive hand task industries.
LE is a painful condition, leading to loss of function of the affected limb. Therefore it can have a major impact on the patient's work and personal life. If untreated, it persists for an average of six to 24 months and associated with significant sickness absence in 5 % of affected working-aged adults. The cost is therefore high, both in terms of loss of productivity and health care utilization.
Many treatments have been advocated in the management of LE, possibly implying that much is unknown about its etiology and how it best should be treated. Systematic reviews have failed to draw any firm conclusions as to what treatment is most effective in managing this condition.
Over the past 10 years acupuncture has gained wider acceptance for treating pain, by both clinicians and consumers of health, and there is some evidence suggesting that acupuncture treatment is effective in of acute symptoms in LE. A recent study supports that also elbow manipulation have a short-term relief of acute symptoms in LE, especially when combined with eccentric exercise. Our study will therefore explore the clinical effectiveness of physiotherapy versus acupuncture treatment of LE, compared with watchful waiting.
Detailed description
The study design is three armed and randomized, single blinded. The study aims, in a pilot stydy, to test if physiotherapy or acupuncture treatment of lateral epicondylitis, compared with watchful waiting, is useful means in pain relief for patients with lateral epicondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture and eccentric exercise | Experimental | Device: Acupuncture, Other: eccentric exerciseTreatment will be performed according to traditional Chinese methods (STRICTA: Standards for reporting interventions in controlled trials of acupunc-ture). Therapists will select points frequently recommended for the treatment of LE. As local point, LI11 and LI10 over the muscular origin of the lateral extensor group of the forearm will be used, and LU5 in the cubical region. LI4 and TE5 will be regional points for pain therapy in the upper limb, GB34 will be used as a distal point for treatment of tendinosis in general, and ST36 for treatment of pain. Needles will be inserted down to the musculature and obtaining De Qi sensation and will remain in situ for 20 min. All patients will receive four treatment sessions; this may be extended to eight depending on patient's pain report and the therapists' clinical evaluation. Maximum treatment period is 4 weeks. Patients will also be instructed in eccentric strength exercises for daily home training from enrolment and 12 weeks forward. |
| Physiotherapy and eccentric exercise | Experimental | Other: Physiotherapy and eccentric exerciseManual techniques as gliding mobilization of elbow, therapists are spezialised in manual therapy. At least four treatment sessions will be performed, but depending on the patient's perceived intensity of pain and the therapists' clinical evaluation, a maximum of eight treatment session can be given. All treatment session will be performed during a period of maximum 4 weeks. In addition, patients will be instructed in eccentric strength exercises for daily home training from enrolment and 12 weeks forward. |
| Watchful waiting and eccentric exercise | Active comparator | Other: Watchful waiting and eccentric exercisePatients will be instructed in eccentric strength exercises for daily home training from enrolment and 12 weeks forward. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Lateral epicondylitis LE (duration > 2 weeks)
- Unilateral localization
- Individuals with average pain of NRS 4 or higher during the last week prior to screening
- Aged between 18 and 67 years
- Written informed consent
Key exclusion criteria (5 listed)
- Corticosteroid injections during the last 4 weeks
- Diseases of the central or peripheral nervous system
- Inflammatory rheumatic diseases
- Radio-ulna or radio humeral osteoarthritis
- Unwilling to participate
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 |
|---|---|---|
| Acupuncture | Device | Acupuncture and eccentric exercise |
| Physiotherapy and eccentric exercise | Other | Physiotherapy and eccentric exercise |
| Watchful waiting and eccentric exercise | Other | Watchful waiting and eccentric exercise |
| eccentric exercise | Other | Acupuncture and eccentric exercise |
Primary outcome
Elbow pain on Numeric Rating Scale (0-10)
Time frame: 12 weeks and 1 year
present, worst and lesser pain during the last week, an average score will be calculated
6 secondary outcomes
The disabilities of the arm shoulder and hand (quick-DASH)
Time frame: 12 weeks and 1 year
Quality of life by EQ-5D
Time frame: 12 weeks and 1 year
Sick listing
Time frame: 12 weeks and 1 year
Patients satisfaction; global perceived effect and satistfaction with treatment
Time frame: 12 weeks and 1 year
Use of analgesics
Time frame: 12 weeks and 1 year
Number of treatment sessions
Time frame: 4 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 20 Dec 2017.
- Derived from this study: PubMed 31516727Bostrom K, Maehlum S, Cvancarova Smastuen M, Storheim K. Clinical comparative effectiveness of acupuncture versus manual therapy treatment of lateral epicondylitis: feasibility randomized clinical trial. Pilot Feasibility Stud. 2019 Sep 7;5:110. doi: 10.1186/s40814-019-0490-x. eCollection 2019.
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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.
Astrid Wahl, PhD study director
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture, Physiotherapy and eccentric exercise and Watchful waiting and eccentric exercise in people with Lateral Epicondylitis, run by Oslo University Hospital at 1 site in Norway.
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 5 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: finished, as of the sponsor's last update on 20 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 Norway. 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?
Elbow pain on Numeric Rating Scale (0-10) (time frame: 12 weeks and 1 year). 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 NCT02321696, 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 20 Dec 2017.