Tennis ElbowNCT04867811
Effect of Transcutaneous Electrical Nerve Stimulation and Cupping Therapy in The Treatment of Tennis Elbow: A Randomized Controlled Trial
A study testing conventional therapy, cupping therapy and TENS in people with Tennis Elbow, run by October 6 University at 1 site in Egypt.
Trial summary
One hundred and twenty patients (67 females and 53 males) with unilateral TE were included in the study from January 2020 to December 2020 and diagnosed by an orthopedist. Their ages ranged between 20 and 50 years old. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- conventional therapy, cupping therapy and TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2020to 20 Dec 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with pain in the lateral epicondylar region, increased pain with pressure and resistance to wrist extension, persistence of symptoms for more than three months, no physical therapy interventions during the last three months
Who cannot join
- patients with bilateral tennis elbow, proximal radio-ulnar joint synovitis, radial nerve entrapment, cervical spine radiculopathy, other diseases like medial epicondylitis, impaired sensibility and paralysis that may affect the outcome measurement and previous injury or surgery in the region of common extensor origin
Trial locations and contacts
1 site in 1 country.
About this study
One hundred and twenty patients (67 females and 53 males) with unilateral TE were included in the study from January 2020 to December 2020 and diagnosed by an orthopedist. Their ages ranged between 20 and 50 years old.
Read the detailed description
They were divided randomly into three groups by lottery method. Group A (n=30) received conventional therapy, group B (n=30) received TENS in addition to conventional therapy, group C received cupping therapy with conventional therapy and group D (n=30) received TENS and cupping therapy plus conventional therapy. All patients read and signed a consent form before participation in this trial. This study was approved by the Ethical Committee of the Faculty of Physical Therapy, October 6 University, Egypt. Patients with pain in the lateral epicondylar region, increased pain with pressure and resistance to wrist extension, persistence of symptoms for more than three months, no physical therapy interventions during the last three months were included in the study while patients with bilateral tennis elbow, proximal radio-ulnar joint synovitis, radial nerve entrapment, cervical spine radiculopathy, other diseases like medial epicondylitis, impaired sensibility and paralysis that may affect the outcome measurement and previous injury or surgery in the region of common extensor origin were excluded from this study.
- Conditions
- Tennis Elbow
- Being tested
- conventional therapy, cupping therapy, TENS, TENS and cupping therapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional therapyOther
conventional therapy
cupping therapyOther
cupping therapy
TENSDevice
transcutaneous electrical nerve stimulation
TENS and cupping therapyOther
TENS and cupping therapy
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | received conventional therapy Receives: Other: conventional therapy |
| group B | Experimental | received TENS in addition to conventional therapy Receives: Other: conventional therapy; Device: TENS |
| group C | Experimental | received cupping therapy with conventional therapy Receives: Other: conventional therapy; Other: cupping therapy |
| group D | Experimental | TENS and cupping therapy plus conventional therapy Receives: Other: conventional therapy; Other: TENS and cupping therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Measured: 4 weeks
Pain-Free Grip Strength
Measured: 4 weeks
Patient-Rated Tennis Elbow Evaluation (PRTEE)
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 posted30 Apr 2021
- Study start12 Jan 2020
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Eldin Mohamed, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867811
- Sponsor's protocol ID
- 7645
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Nerve Stimulation and Cupping Therapy in The Treatment of Tennis Elbow: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04867811
- Acronym / sponsor ID
- 7645
- Conditions
- Tennis Elbow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 30 Apr 2021 (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.
One hundred and twenty patients (67 females and 53 males) with unilateral TE were included in the study from January 2020 to December 2020 and diagnosed by an orthopedist. Their ages ranged between 20 and 50 years old.
Detailed description
They were divided randomly into three groups by lottery method. Group A (n=30) received conventional therapy, group B (n=30) received TENS in addition to conventional therapy, group C received cupping therapy with conventional therapy and group D (n=30) received TENS and cupping therapy plus conventional therapy. All patients read and signed a consent form before participation in this trial. This study was approved by the Ethical Committee of the Faculty of Physical Therapy, October 6 University, Egypt. Patients with pain in the lateral epicondylar region, increased pain with pressure and resistance to wrist extension, persistence of symptoms for more than three months, no physical therapy interventions during the last three months were included in the study while patients with bilateral tennis elbow, proximal radio-ulnar joint synovitis, radial nerve entrapment, cervical spine radiculopathy, other diseases like medial epicondylitis, impaired sensibility and paralysis that may affect the outcome measurement and previous injury or surgery in the region of common extensor origin were excluded from this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Other: conventional therapyreceived conventional therapy |
| group B | Experimental | Other: conventional therapy, Device: TENSreceived TENS in addition to conventional therapy |
| group C | Experimental | Other: conventional therapy, Other: cupping therapyreceived cupping therapy with conventional therapy |
| group D | Experimental | Other: conventional therapy, Other: TENS and cupping therapyTENS and cupping therapy plus conventional therapy |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with pain in the lateral epicondylar region, increased pain with pressure and resistance to wrist extension, persistence of symptoms for more than three months, no physical therapy interventions during the last three months
Key exclusion criteria (1 listed)
- patients with bilateral tennis elbow, proximal radio-ulnar joint synovitis, radial nerve entrapment, cervical spine radiculopathy, other diseases like medial epicondylitis, impaired sensibility and paralysis that may affect the outcome measurement and previous injury or surgery in the region of common extensor origin
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 |
|---|---|---|
| conventional therapyconventional therapy | Other | group A, group B, group C, group D |
| cupping therapycupping therapy | Other | group C |
| TENStranscutaneous electrical nerve stimulation | Device | group B |
| TENS and cupping therapyTENS and cupping therapy | Other | group D |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 4 weeks
Pain-Free Grip Strength
Time frame: 4 weeks
Patient-Rated Tennis Elbow Evaluation (PRTEE)
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 30 Apr 2021.
- 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 conventional therapy, cupping therapy and TENS in people with Tennis Elbow, run by October 6 University at 1 site in Egypt.
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 1 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 30 Apr 2021. 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 Egypt. 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?
Visual Analog Scale (VAS) (time frame: 4 weeks). The study lists 3 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 30 Apr 2021.