Lateral EpicondylitisNCT03848117
Effects of Mulligan and Cyriax Approach in Patients With Subacute Lateral Epicondylitis.
A study testing Cyriax approach i.e. DTF massage and Mill's manipulation and Mulligan approach i.e. Taping and MWM in people with Lateral Epicondylitis, run by Isra University at 1 site in Pakistan.
Trial summary
Lateral epicondylitis (LE) is a pain causing musculoskeletal disease which mainly occurs due to the over exertion or over use of extensors of wrist mainly ECRB and pain is felt at the origin of common extensor tendon. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Cyriax approach i.e. DTF massage and Mill's manipulation and Mulligan approach i.e. Taping and MWM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2019to 15 Oct 2019
- 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
- Age group 20-50 years of both gender.
- Vas < 7
- Positive mills test and cozens test.
- Local tenderness on palpation over lateral epicondyle of the humerus.
- From sub-acute to chronic more than 2 weeks.
Who cannot join
- Any previous pathology of bone around elbow.
- Corticosteroid injection in the preceeding 3 months.
- Absence of clinical signs of tennis elbow.
- Any other systemic illness like metabolic, metastatic, infective disorders.
- Any other neurological abnormalities.
- Allergies to Mulligan tape.
Trial locations and contacts
1 site in 1 country.
About this study
Lateral epicondylitis (LE) is a pain causing musculoskeletal disease which mainly occurs due to the over exertion or over use of extensors of wrist mainly ECRB and pain is felt at the origin of common extensor tendon. This study was focused to assess the effectiveness of cyriax approach and mulligan approach to improve the functional status of sub acute lateral epicondylitis patients through patient related tennis elbow evaluation form.
Read the detailed description
A total of 39 athletes with knee pain were recruited and randomly divided into two groups. 30 subjects fulfilled the inclusion criteria and were part of this trial, 15 in each group.The data was collected through general demographic questionnaire, PRTEE questionnaire to determine the level of pain and functional disability and Hand grip strength chart to measure grip strength while having epicondylitis.
- Conditions
- Lateral Epicondylitis
- Being tested
- Cyriax approach i.e. DTF massage and Mill's manipulation, Mulligan approach i.e. Taping and MWM
- Keywords
- Patient Rated Tennis Elbow Evaluation (PRTEE), Mobilization with movement, Deep Transverse friction massage
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyriax approach i.e. DTF massage and Mill's manipulationOther
Each patient in group I i.e. Cyriax group was given 20-minute session. Each session started in sitting position and initially deep transverse friction massage was done at lateral compartment of the elbow joint and immediately after that mill's manipulation at elbow joint with flexion at wrist joint in pronated arm position. This session was repeated three times a week for one month (Total 12 sessions/ one month).
Mulligan approach i.e. Taping and MWMOther
Each patient in group II i.e. Mulligan group was given 30 to 45-minute session. Each session started in sitting position and it included mobilization with movement which was given in such a way that initially lateral glide at elbow joint was performed and after holding it, I asked the patient to make a fist and open the fist. In this way, I repeated this procedure 36 times and after 12 repetitions, a short rest period was given. Taping was applied after mobilization around the elbow joint over extensor carpi radialis muscles. This session was repeated three times a week for one month (Total 12 sessions/ one month).
| Study group | Role | What they receive |
|---|---|---|
| (DTF massage & Mill's manipulation)(Group 1) | Active comparator | For any given subject in group 1, PRTEE pain and functional disability evaluations and Hand grip strength were completed on the same day. Then each subject in 1st group completed 4 weeks of physical therapy sessions which were aimed to decrease pain, increase functional activity level, and improve hand grip strength. Each subject was evaluated for changes in symptoms on 1st week, 2nd week, 3rd week and 4th week. Receives: Other: Cyriax approach i.e. DTF massage and Mill's manipulation |
| ( Taping & MWM) (Group 2). | Active comparator | For any given subject in group 2, PRTEE pain and functional disability evaluations and Hand grip strength were completed on the same day. Then each subject in second group completed 4 weeks of physical therapy sessions which were aimed to decrease pain, increase functional activity level, and improve hand grip strength. Each subject was evaluated for changes in symptoms on 1st week, 2nd week, 3rd week and 4th week. Receives: Other: Mulligan approach i.e. Taping and MWM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient related tennis elbow evaluation pain scale
Pain associated with daily tasks is measured through Patient related tennis elbow evaluation pain scale with categories as "0" for no pain and "10" for worst imaginable pain.
Measured: Upto 4 weeks
Patient related tennis elbow evaluation functional disability scale
Degree of difficulty in performing daily tasks associated with elbow joint is measured through Patient related tennis elbow evaluation functional disability scale in categories as "0" for no difficulty in task and "10" for unable to do a task.
Measured: Upto 4 weeks
Secondary outcomes (1)
Hand grip strength chart index
It is also measured through hand grip dynamo meter with reference values according to gender description.
Measured: Upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start1 Mar 2019
- Primary completion30 Sep 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies 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
- Model description
- Patients were randomly assigned into two groups: Cyriax Approach group and Mulligan approach group. A coin was flipped at start of data collection for the first patient to be assigned odd number and included in cyriax group. Later on odd and even numbered patients were included in specific group. Additionally, data was collected from lateral epicondylitis patients visiting the DHQ Hospital Bahawalnagar.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sammar Abbas, Isra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848117
- Sponsor's protocol ID
- IIRS-1702-M.Phil OPT-006
- Status last verified
- Nov 2019
- First submitted
- 26 Jan 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mulligan and Cyriax Approach in Patients With Subacute Lateral Epicondylitis.
- ClinicalTrials.gov ID
- NCT03848117
- Acronym / sponsor ID
- IIRS-1702-M.Phil OPT-006
- Conditions
- Lateral Epicondylitis
- Keywords
- Patient Rated Tennis Elbow Evaluation (PRTEE), Mobilization with movement, Deep Transverse friction massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 20 Feb 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 (LE) is a pain causing musculoskeletal disease which mainly occurs due to the over exertion or over use of extensors of wrist mainly ECRB and pain is felt at the origin of common extensor tendon. This study was focused to assess the effectiveness of cyriax approach and mulligan approach to improve the functional status of sub acute lateral epicondylitis patients through patient related tennis elbow evaluation form.
Detailed description
A total of 39 athletes with knee pain were recruited and randomly divided into two groups. 30 subjects fulfilled the inclusion criteria and were part of this trial, 15 in each group.The data was collected through general demographic questionnaire, PRTEE questionnaire to determine the level of pain and functional disability and Hand grip strength chart to measure grip strength while having epicondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomly assigned into two groups: Cyriax Approach group and Mulligan approach group. A coin was flipped at start of data collection for the first patient to be assigned odd number and included in cyriax group. Later on odd and even numbered patients were included in specific group. Additionally, data was collected from lateral epicondylitis patients visiting the DHQ Hospital Bahawalnagar.
| Arm | Type | Receives |
|---|---|---|
| (DTF massage & Mill's manipulation)(Group 1) | Active comparator | Other: Cyriax approach i.e. DTF massage and Mill's manipulationFor any given subject in group 1, PRTEE pain and functional disability evaluations and Hand grip strength were completed on the same day. Then each subject in 1st group completed 4 weeks of physical therapy sessions which were aimed to decrease pain, increase functional activity level, and improve hand grip strength. Each subject was evaluated for changes in symptoms on 1st week, 2nd week, 3rd week and 4th week. |
| ( Taping & MWM) (Group 2). | Active comparator | Other: Mulligan approach i.e. Taping and MWMFor any given subject in group 2, PRTEE pain and functional disability evaluations and Hand grip strength were completed on the same day. Then each subject in second group completed 4 weeks of physical therapy sessions which were aimed to decrease pain, increase functional activity level, and improve hand grip strength. Each subject was evaluated for changes in symptoms on 1st week, 2nd week, 3rd week and 4th week. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age group 20-50 years of both gender.
- Vas < 7
- Positive mills test and cozens test.
- Local tenderness on palpation over lateral epicondyle of the humerus.
- From sub-acute to chronic more than 2 weeks.
Key exclusion criteria (6 listed)
- Any previous pathology of bone around elbow.
- Corticosteroid injection in the preceeding 3 months.
- Absence of clinical signs of tennis elbow.
- Any other systemic illness like metabolic, metastatic, infective disorders.
- Any other neurological abnormalities.
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 |
|---|---|---|
| Cyriax approach i.e. DTF massage and Mill's manipulationEach patient in group I i.e. Cyriax group was given 20-minute session. Each session started in sitting position and initially deep transverse friction massage was done at lateral compartment of the elbow joint and immediately after that mill's manipulation at elbow joint with flexion at wrist joint in pronated arm position. This session was repeated three times a week for one month (Total 12 sessions/ one month). | Other | (DTF massage & Mill's manipulation)(Group 1) |
| Mulligan approach i.e. Taping and MWMEach patient in group II i.e. Mulligan group was given 30 to 45-minute session. Each session started in sitting position and it included mobilization with movement which was given in such a way that initially lateral glide at elbow joint was performed and after holding it, I asked the patient to make a fist and open the fist. In this way, I repeated this procedure 36 times and after 12 repetitions, a short rest period was given. Taping was applied after mobilization around the elbow joint over extensor carpi radialis muscles. This session was repeated three times a week for one month (Total 12 sessions/ one month). | Other | ( Taping & MWM) (Group 2). |
Primary outcome
Patient related tennis elbow evaluation pain scale
Time frame: Upto 4 weeks
Pain associated with daily tasks is measured through Patient related tennis elbow evaluation pain scale with categories as "0" for no pain and "10" for worst imaginable pain.
Patient related tennis elbow evaluation functional disability scale
Time frame: Upto 4 weeks
Degree of difficulty in performing daily tasks associated with elbow joint is measured through Patient related tennis elbow evaluation functional disability scale in categories as "0" for no difficulty in task and "10" for unable to do a task.
1 secondary outcome
Hand grip strength chart index
Time frame: Upto 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 13 Nov 2019.
- Individual participant dataSharing planned: Yes
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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 Cyriax approach i.e. DTF massage and Mill's manipulation and Mulligan approach i.e. Taping and MWM in people with Lateral Epicondylitis, run by Isra University at 1 site in Pakistan.
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 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 13 Nov 2019. 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 Pakistan. 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?
Patient related tennis elbow evaluation pain scale (time frame: Upto 4 weeks). The study lists 2 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 13 Nov 2019.