Pain in Arm, UnspecifiedNCT03968796
Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) and Kinesio Taping in Patients With Lateral Epicondylitis
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Kinesio Taping in people with Pain in Arm, Unspecified and Tenosynovitis Elbow, run by European University of Lefke.
Trial summary
Lateral epicondylitis is the most common condition affecting the elbow and characterized by pain over the lateral epicondyle. The aim of this study was to determine and compare the efficacy of TENS and Kinesio Taping in lateral epicondylitis. Read more about this study
- Who is it for?
- Ages 19 to 72 years
- Conditions the study is for
- Pain in Arm, Unspecified, Tenosynovitis Elbow, Lateral Epicondylitis (Tennis Elbow) Bilateral
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS) and Kinesio Taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2013to 31 Aug 2013
- 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 19 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 19 to 72
- Enough cognitive ability to fill clinical assessment forms
- Agreed to participate in the study
Who cannot join
- Severe or progressive neurological deficits
- Severe psychiatric disease history, substance and/or alcohol dependence,
- Uncontrolled diabetes mellitus, malignancy, osteoporosis
- A history of inflammatory or infectious disease
- A skin allergy story
- Previously undergone physical therapy due to lateral epicondylitis
About this study
Official title: TENS and Kinesio Tape for Treatment Lateral Epicondylitis
Lateral epicondylitis is the most common condition affecting the elbow and characterized by pain over the lateral epicondyle. The aim of this study was to determine and compare the efficacy of TENS and Kinesio Taping in lateral epicondylitis.
Read the detailed description
In this prospective-randomized, assessor blinded controlled trial, seventy-eight patients (63 women, 15 men, mean age 47,5 ±7,94 years) with lateral epicondylitis were enrolled. Patients were allocated into 4 treatment groups: Group 1 received TENS and Kinesio Taping, group 2 received TENS+sham Kinesio Taping, group 3 received sham TENS+ Kinesio Taping and group 4 received sham TENS+sham Kinesio Taping. TENS was applied for 10 sessions and Kinesio Taping for 4 times in 10 days. All patients were given a progressive exercise program and were informed about the disease. All patients were told to take paracetamol 500 mg if their pain is severe and to note the number of the paracetamol taken.
Outcome measures were pain-free grip strength, pressure pain threshold and pain severity at rest, night and forced wrist extension test. Patient-rated tennis elbow evaluation (PRTEE) was used to determine functional status. Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.
- Conditions
- Pain in Arm, Unspecified, Tenosynovitis Elbow, Lateral Epicondylitis (Tennis Elbow) Bilateral
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS), Sham Transcutaneous Electrical Nerve Stimulation (TENS), Kinesio Taping, Sham Kinesio Taping
- Keywords
- Kinesio Taping, Lateral epicondylitis, Tennis elbow, TENS
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Other
Sham Transcutaneous Electrical Nerve Stimulation (TENS)Other
Kinesio TapingOther
Sham Kinesio TapingOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | A total of 10 sessions of TENS were administered to each patient for 20 minutes daily.
Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment. Receives: Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Kinesio Taping |
| Group 2 | Active comparator | A total of 10 sessions of TENS were administered to each patient for 20 minutes daily.
Sham Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment, but taping was done incorrectly. Receives: Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Sham Kinesio Taping |
| Group 3 | Active comparator | A total of 10 sessions of Sham TENS(the device was not operated) were administered to each patient for 20 minutes daily.
Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment. Receives: Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS); Other: Kinesio Taping |
| Group 4 | Placebo comparator | A total of 10 sessions of Sham TENS(the device was not operated) were administered to each patient for 20 minutes daily.
Sham Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment, but taping was done incorrectly. Receives: Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS); Other: Sham Kinesio Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-free grip strength
Hand grasping force with hand dynamometer was evaluated. The grip force was measured with the hand dynamometer as the maximum grip force, while the patient was sitting in the chair with 0 degrees of abduction and neutral position and the elbow with 90 degrees of flexion. Both sides were firstly measured on 2 sides and then averaged. 30 second rest periods were given between measurements.Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.
Measured: 12 week
Pain severity at rest, night and forced wrist extension test
Pain was evaluated with a 10 cm scale horizantal VAS. The head of the line was painless and the end was the most severe pain. The patient was asked to mark the most appropriate location for pain on the scale. Pain severity at rest, at night and forced wrist extension test was evaluated by visual analog scale (VAS). Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.
Measured: 12 week
Pressure pain threshold
Pressure pain threshold was evaluated by algometer. The pressure pain threshold was measured at the lateral epicondyle with an algae before starting with a painless side in both extremities. Algometer is an instrument that measures the pain threshold and pain tolerance objectively. In the sitting position, the shoulder is evaluated at 30 ° abduction, and the elbow at 90 ° flexion over the lateral epicondyle (1 cm 2 area).
In our study, the algometer was applied vertically to the most painful point by increasing the pressure by 1 kg / cm2 every 3 seconds until the patient felt pain. The pressure value that caused the pain feeling was determined as the pain threshold. In the 20-second intervals, the lowest pressure value was taken as the pain threshold between the three measurements. Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.
Measured: 12 week
Patient-rated tennis elbow evaluation (PRTEE)
Patient-rated tennis elbow evaluation (PRTEE)was used to determine functional status. The PRTEE (Patient Based Inventory Evaluation Questionnaire) is a practical questionnaire that measures elbow pain and function and has been validated in lateral epicondylitis. It consists of a total of 15 questions about pain, function and daily activities. In our study, pain, function and total score were calculated for each patient. The pain score is obtained by summing the points given to the 5 questions related to the pain in the affected arm (minimum score 0, maximum score 50). Function score is obtained by dividing the scores of 10 questions evaluating the function in the affected arm and dividing by 2 (minimum score 0, maximum score 50). The total score is the sum of the pain score and function score (minimum score 0, maximum score of 100).Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Jun 2013
- Primary completion31 Aug 2013
- Study completion31 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain in Arm, UnspecifiedStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University of Lefke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Telli, European University of Lefke
- Investigators
- Hilal Telli, MD, Principal investigator, European University of Lefke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968796
- Sponsor's protocol ID
- Lateral Epicondylitis
- Status last verified
- May 2019
- First submitted
- 28 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients were allocated into 4 treatment groups: Group 1 received TENS and Kinesio Taping, group 2 received TENS + sham Kinesio Taping, group 3 received sham TENS + Kinesio Taping and group 4 received sham TENS + sham Kinesio Taping. TENS was applied for 10 sessions and Kinesio Taping for 4 times in 10 days. All patients were given a progressive exercise program and were informed about the disease. All patients were told to take paracetamol 500 mg if their pain is severe and to note the number of the paracetamol taken. Outcome measures were pain-free grip strength, pressure pain threshold and pain severity at rest, night and forced wrist extension test. Patient-rated tennis elbow evaluation (PRTEE) was used to determine functional status. Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TENS and Kinesio Tape for Treatment Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT03968796
- Acronym / sponsor ID
- Lateral Epicondylitis
- Conditions
- Pain in Arm, Unspecified, Tenosynovitis Elbow, Lateral Epicondylitis (Tennis Elbow) Bilateral
- Keywords
- Kinesio Taping, Lateral epicondylitis, Tennis elbow, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- European University of LefkeUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 31 Aug 2013 (actual)
- Study completion
- 31 Aug 2013 (actual)
- First posted
- 30 May 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.
Lateral epicondylitis is the most common condition affecting the elbow and characterized by pain over the lateral epicondyle. The aim of this study was to determine and compare the efficacy of TENS and Kinesio Taping in lateral epicondylitis.
Detailed description
In this prospective-randomized, assessor blinded controlled trial, seventy-eight patients (63 women, 15 men, mean age 47,5 ±7,94 years) with lateral epicondylitis were enrolled. Patients were allocated into 4 treatment groups: Group 1 received TENS and Kinesio Taping, group 2 received TENS+sham Kinesio Taping, group 3 received sham TENS+ Kinesio Taping and group 4 received sham TENS+sham Kinesio Taping. TENS was applied for 10 sessions and Kinesio Taping for 4 times in 10 days. All patients were given a progressive exercise program and were informed about the disease. All patients were told to take paracetamol 500 mg if their pain is severe and to note the number of the paracetamol taken.
Outcome measures were pain-free grip strength, pressure pain threshold and pain severity at rest, night and forced wrist extension test. Patient-rated tennis elbow evaluation (PRTEE) was used to determine functional status. Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Transcutaneous Electrical Nerve Stimulation (TENS), Other: Kinesio TapingA total of 10 sessions of TENS were administered to each patient for 20 minutes daily. Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment. |
| Group 2 | Active comparator | Other: Transcutaneous Electrical Nerve Stimulation (TENS), Other: Sham Kinesio TapingA total of 10 sessions of TENS were administered to each patient for 20 minutes daily. Sham Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment, but taping was done incorrectly. |
| Group 3 | Active comparator | Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS), Other: Kinesio TapingA total of 10 sessions of Sham TENS(the device was not operated) were administered to each patient for 20 minutes daily. Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment. |
| Group 4 | Placebo comparator | Other: Sham Transcutaneous Electrical Nerve Stimulation (TENS), Other: Sham Kinesio TapingA total of 10 sessions of Sham TENS(the device was not operated) were administered to each patient for 20 minutes daily. Sham Kinesio taping was performed a total of 3 sessions on the 1st, 4th and 7th days of treatment, but taping was done incorrectly. |
Who may qualify
- Ages
- 19 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 19 to 72
- Enough cognitive ability to fill clinical assessment forms
- Agreed to participate in the study
Key exclusion criteria (6 listed)
- Severe or progressive neurological deficits
- Severe psychiatric disease history, substance and/or alcohol dependence,
- Uncontrolled diabetes mellitus, malignancy, osteoporosis
- A history of inflammatory or infectious disease
- A skin allergy story
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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Other | Group 1, Group 2 |
| Sham Transcutaneous Electrical Nerve Stimulation (TENS) | Other | Group 3, Group 4 |
| Kinesio Taping | Other | Group 1, Group 3 |
| Sham Kinesio Taping | Other | Group 2, Group 4 |
Primary outcome
Pain-free grip strength
Time frame: 12 week
Hand grasping force with hand dynamometer was evaluated. The grip force was measured with the hand dynamometer as the maximum grip force, while the patient was sitting in the chair with 0 degrees of abduction and neutral position and the elbow with 90 degrees of flexion. Both sides were firstly measured on 2 sides and then averaged. 30 second rest periods were given between measurements.Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.
Pain severity at rest, night and forced wrist extension test
Time frame: 12 week
Pain was evaluated with a 10 cm scale horizantal VAS. The head of the line was painless and the end was the most severe pain. The patient was asked to mark the most appropriate location for pain on the scale. Pain severity at rest, at night and forced wrist extension test was evaluated by visual analog scale (VAS). Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.
Pressure pain threshold
Time frame: 12 week
Pressure pain threshold was evaluated by algometer. The pressure pain threshold was measured at the lateral epicondyle with an algae before starting with a painless side in both extremities. Algometer is an instrument that measures the pain threshold and pain tolerance objectively. In the sitting position, the shoulder is evaluated at 30 ° abduction, and the elbow at 90 ° flexion over the lateral epicondyle (1 cm 2 area). In our study, the algometer was applied vertically to the most painful point by increasing the pressure by 1 kg / cm2 every 3 seconds until the patient felt pain. The pressure value that caused the pain feeling was determined as the pain threshold. In the 20-second intervals, the lowest pressure value was taken as the pain threshold between the three measurements. Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.
Patient-rated tennis elbow evaluation (PRTEE)
Time frame: 12 week
Patient-rated tennis elbow evaluation (PRTEE)was used to determine functional status. The PRTEE (Patient Based Inventory Evaluation Questionnaire) is a practical questionnaire that measures elbow pain and function and has been validated in lateral epicondylitis. It consists of a total of 15 questions about pain, function and daily activities. In our study, pain, function and total score were calculated for each patient. The pain score is obtained by summing the points given to the 5 questions related to the pain in the affected arm (minimum score 0, maximum score 50). Function score is obtained by dividing the scores of 10 questions evaluating the function in the affected arm and dividing by 2 (minimum score 0, maximum score 50). The total score is the sum of the pain score and function score (minimum score 0, maximum score of 100).Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.
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 Jun 2019.
- Individual participant dataSharing planned: No. Patients were allocated into 4 treatment groups: Group 1 received TENS and Kinesio Taping, group 2 received TENS + sham Kinesio Taping, group 3 received sham TENS + Kinesio Taping and group 4 received sham TENS + sham Kinesio Taping. TENS was applied for 10 sessions and Kinesio Taping for 4 times in 10 days. All patients were given a progressive exercise program and were informed about the disease. All patients were told to take paracetamol 500 mg if their pain is severe and to note the number of the paracetamol taken. Outcome measures were pain-free grip strength, pressure pain threshold and pain severity at rest, night and forced wrist extension test. Patient-rated tennis elbow evaluation (PRTEE) was used to determine functional status. Patients were assessed for outcome measures at screening, after treatment (day 10) and 12th week after the treatment.
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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.
Hilal Telli, MD principal investigator
European University of Lefke
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Kinesio Taping in people with Pain in Arm, Unspecified and Tenosynovitis Elbow, run by European University of Lefke.
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 3 inclusion and 6 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 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain-free grip strength (time frame: 12 week). 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?
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 Jun 2019.