Lateral EpicondylitisNCT05413967
Effects of Mills Manipulation and Nirschel Exercises in Patients With Lateral Epicondylitis
A study testing Mills manipulation in addition to myofasical release therapy and Nirschl exercises in addition to myofascial release therapy in people with Lateral Epicondylitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
To find effects of mills manipulation versus NIRSCHL EXERCISES on pain ,strength and function in patients with lateral epicondylitis. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Mills manipulation in addition to myofasical release therapy and Nirschl exercises in addition to myofascial release therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 31 Mar 2023
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pain on lateral epicondyle of humerus when palpated, in the age group of 40-60 years
- Both male and female are included
- Unilateral symptomatic lateral epicondylitis
- Tenderness over palpation of extensor carpi radialis brevis muscle muscle (ECRB)
- Patients with positive cozens test (resisted wrist extension and radial deviation is painful) ,mills test (passive elbow extension \& wrist flexion is painful) and maudsley test(resisted middle finger extension is painful)
- Patients having symptoms of lateral epicondylitis for > 3 months
Who cannot join
- Radial nerve entrapment
- Cervical radiculopathy
- Corticosteroid injection within 4 weeks
- Had received any conservative treatment for lateral epicondylitis in last 4 weeks before entering the study
- Post-surgery patients of lateral epicondylitis
- Radiological findings of extensor tendon calcification
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
PSRD hospital Ferozpur Road LAHORE
Lahore, Punjab Province
SABA RAFIQUE, ppdpt, 03034045433, saba.rafique@riphah.edu.pk
Sadia Moazzam, MSPT-OM
About this study
Official title: Effects of Mills Manipulation Versus NIRSCHL Exercises on Pain, Strength and Function in Patients With Lateral Epicondylitis
To find effects of mills manipulation versus NIRSCHL EXERCISES on pain ,strength and function in patients with lateral epicondylitis.
Read the detailed description
Lateral epicondylitis is also known as tennis elbow, an overuse injury that is characterized by pain and tenderness over the lateral epicondyle. The exact etiology has not been well identified, however its commonly associated with repetitive micro trauma from excessive gripping, wrist extension radial deviation or forearm supination. Extensor carpi radialis brevis is the most affected muscle. The aim of this study is to access the effects of mills manipulation versus Nirschl exercises on pain, strength, and function in patients with lateral epicondylitis.
This study will be a Randomized Clinical trial and will be conducted at Pakistan society for rehabilitation of disabled and Mayo Hospital in Lahore. Patients of aged 20-40 years having insidious onset of lateral elbow pain with positive cozens test, Mills test and Maudsley test will be taken. Patients with radial nerve entrapment, cervical radiculopathy and those receiving injections of corticosteroids in last 4 weeks are excluded. The study will include 32 patients randomly divided into two groups A and group B. The study will be completed within the time duration of 10 months after approval of synopsis. Group A will receive mills manipulation while Group B will receive Nirschl exercises. myofascial release therapy will be given to both groups as baseline. both groups will receive 3 sessions per week for 4 weeks (12 sessions), data will be taken by using numeric pain rating scale for pain, hand dynamometer for grip strength and Patient rated tennis elbow evaluation for evaluation of function, at the start of treatment and the end of treatment session. Data will be analysed on SPSS-25.
Key words: lateral epicondylitis, mills manipulation, Nirschl exercises, Patient rated tennis elbow evaluation
- Conditions
- Lateral Epicondylitis
- Being tested
- Mills manipulation in addition to myofasical release therapy, Nirschl exercises in addition to myofascial release therapy
- Keywords
- lateral epicondylitis ,Mills Manipulation,NIRSCHL exercises
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mills manipulation in addition to myofasical release therapyOther
Group A will receive Mills manipulation in addition to myofasical release therapy as baselin
Nirschl exercises in addition to myofascial release therapyOther
Group B will receive Nirschl exercises in addition to myofascial release therapy as baseline
| Study group | Role | What they receive |
|---|---|---|
| Mills manipulation in addition to myofasical release therapy | Experimental | mills manipulation Receives: Other: Mills manipulation in addition to myofasical release therapy |
| Nirschl exercises in addition to myofascial release therapy | Experimental | Nirschel exercises Receives: Other: Nirschl exercises in addition to myofascial release therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating scale (NPRS)
The NPRS is used to access the patient intensity of pain. Its score ranges from 0-10 with 0 is being the least painful while 10 is worst. Patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the last 24 hours. The average of the 3 ratings is used to represent the patient's level of pain over the previous 24 hours. The NPRS is found to be valid and reliable method for measuring patients perceived pain.
Measured: 10 months
Hand dynamometer
Hand dynamometer is used to measure the grip strength of the patients. It is considered as a primary clinical measure according to internationally accepted normal hand grip strength ratings in Kgs in patients with various musculoskeletal conditions associated with decreased hand grip strength.
Measured: 10 MONTHS
Patient Rated Tennis Elbow Evaluation(PRTEE)
Patient related tennis elbow evaluation is used to access pain and functional disability of LE patients. The index has two subscales,5 questions are related to pain are scored 0-10, for each question related to pain 0 refereed to no pain while 10 referred as worst pain imaginable. The functional disability scale 0 referred to no difficulty while 10 being referred to unable to do.PRTEE is a valid and reliable instrument for LE patients.
Measured: 10 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Mar 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Riphah International UniversityThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saba Rafique, ppdpt, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413967
- Sponsor's protocol ID
- REC/RCR&AHS/22/0129
- Status last verified
- Jun 2022
- First submitted
- 7 Jun 2022
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pitsillides A, Stasinopoulos D. Cyriax Friction Massage-Suggestions for Improvements. Medicina (Kaunas). 2019 May 21;55(5):185. doi: 10.3390/medicina55050185.
PubMed 31117314Ma KL, Wang HQ. Management of Lateral Epicondylitis: A Narrative Literature Review. Pain Res Manag. 2020 May 5;2020:6965381. doi: 10.1155/2020/6965381. eCollection 2020.
PubMed 32454922Landesa-Pineiro L, Leiros-Rodriguez R. Physiotherapy treatment of lateral epicondylitis: A systematic review. J Back Musculoskelet Rehabil. 2022;35(3):463-477. doi: 10.3233/BMR-210053.
PubMed 34397403Yan C, Xiong Y, Chen L, Endo Y, Hu L, Liu M, Liu J, Xue H, Abududilibaier A, Mi B, Liu G. A comparative study of the efficacy of ultrasonics and extracorporeal shock wave in the treatment of tennis elbow: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2019 Aug 6;14(1):248. doi: 10.1186/s13018-019-1290-y.
PubMed 31387611
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mills Manipulation Versus NIRSCHL Exercises on Pain, Strength and Function in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT05413967
- Acronym / sponsor ID
- REC/RCR&AHS/22/0129
- Conditions
- Lateral Epicondylitis
- Keywords
- lateral epicondylitis ,Mills Manipulation,NIRSCHL exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 10 Jun 2022 (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.
To find effects of mills manipulation versus NIRSCHL EXERCISES on pain ,strength and function in patients with lateral epicondylitis.
Detailed description
Lateral epicondylitis is also known as tennis elbow, an overuse injury that is characterized by pain and tenderness over the lateral epicondyle. The exact etiology has not been well identified, however its commonly associated with repetitive micro trauma from excessive gripping, wrist extension radial deviation or forearm supination. Extensor carpi radialis brevis is the most affected muscle. The aim of this study is to access the effects of mills manipulation versus Nirschl exercises on pain, strength, and function in patients with lateral epicondylitis.
This study will be a Randomized Clinical trial and will be conducted at Pakistan society for rehabilitation of disabled and Mayo Hospital in Lahore. Patients of aged 20-40 years having insidious onset of lateral elbow pain with positive cozens test, Mills test and Maudsley test will be taken. Patients with radial nerve entrapment, cervical radiculopathy and those receiving injections of corticosteroids in last 4 weeks are excluded. The study will include 32 patients randomly divided into two groups A and group B. The study will be completed within the time duration of 10 months after approval of synopsis. Group A will receive mills manipulation while Group B will receive Nirschl exercises. myofascial release therapy will be given to both groups as baseline. both groups will receive 3 sessions per week for 4 weeks (12 sessions), data will be taken by using numeric pain rating scale for pain, hand dynamometer for grip strength and Patient rated tennis elbow evaluation for evaluation of function, at the start of treatment and the end of treatment session. Data will be analysed on SPSS-25.
Key words: lateral epicondylitis, mills manipulation, Nirschl exercises, Patient rated tennis elbow evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mills manipulation in addition to myofasical release therapy | Experimental | Other: Mills manipulation in addition to myofasical release therapymills manipulation |
| Nirschl exercises in addition to myofascial release therapy | Experimental | Other: Nirschl exercises in addition to myofascial release therapyNirschel exercises |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pain on lateral epicondyle of humerus when palpated, in the age group of 40-60 years
- Both male and female are included
- Unilateral symptomatic lateral epicondylitis
- Tenderness over palpation of extensor carpi radialis brevis muscle muscle (ECRB)
- Patients with positive cozens test (resisted wrist extension and radial deviation is painful) ,mills test (passive elbow extension \& wrist flexion is painful) and maudsley test(resisted middle finger extension is painful)
Key exclusion criteria (6 listed)
- Radial nerve entrapment
- Cervical radiculopathy
- Corticosteroid injection within 4 weeks
- Had received any conservative treatment for lateral epicondylitis in last 4 weeks before entering the study
- Post-surgery patients of lateral epicondylitis
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 |
|---|---|---|
| Mills manipulation in addition to myofasical release therapyGroup A will receive Mills manipulation in addition to myofasical release therapy as baselin | Other | Mills manipulation in addition to myofasical release therapy |
| Nirschl exercises in addition to myofascial release therapyGroup B will receive Nirschl exercises in addition to myofascial release therapy as baseline | Other | Nirschl exercises in addition to myofascial release therapy |
Primary outcome
Numeric Pain Rating scale (NPRS)
Time frame: 10 months
The NPRS is used to access the patient intensity of pain. Its score ranges from 0-10 with 0 is being the least painful while 10 is worst. Patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the last 24 hours. The average of the 3 ratings is used to represent the patient's level of pain over the previous 24 hours. The NPRS is found to be valid and reliable method for measuring patients perceived pain.
Hand dynamometer
Time frame: 10 MONTHS
Hand dynamometer is used to measure the grip strength of the patients. It is considered as a primary clinical measure according to internationally accepted normal hand grip strength ratings in Kgs in patients with various musculoskeletal conditions associated with decreased hand grip strength.
Patient Rated Tennis Elbow Evaluation(PRTEE)
Time frame: 10 Months
Patient related tennis elbow evaluation is used to access pain and functional disability of LE patients. The index has two subscales,5 questions are related to pain are scored 0-10, for each question related to pain 0 refereed to no pain while 10 referred as worst pain imaginable. The functional disability scale 0 referred to no difficulty while 10 being referred to unable to do.PRTEE is a valid and reliable instrument for LE patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Background: PubMed 31117314Pitsillides A, Stasinopoulos D. Cyriax Friction Massage-Suggestions for Improvements. Medicina (Kaunas). 2019 May 21;55(5):185. doi: 10.3390/medicina55050185.
- Background: PubMed 32454922Ma KL, Wang HQ. Management of Lateral Epicondylitis: A Narrative Literature Review. Pain Res Manag. 2020 May 5;2020:6965381. doi: 10.1155/2020/6965381. eCollection 2020.
- Background: PubMed 34397403Landesa-Pineiro L, Leiros-Rodriguez R. Physiotherapy treatment of lateral epicondylitis: A systematic review. J Back Musculoskelet Rehabil. 2022;35(3):463-477. doi: 10.3233/BMR-210053.
- Background: PubMed 31387611Yan C, Xiong Y, Chen L, Endo Y, Hu L, Liu M, Liu J, Xue H, Abududilibaier A, Mi B, Liu G. A comparative study of the efficacy of ultrasonics and extracorporeal shock wave in the treatment of tennis elbow: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2019 Aug 6;14(1):248. doi: 10.1186/s13018-019-1290-y.
- 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.
Saba Rafique, ppdpt principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mills manipulation in addition to myofasical release therapy and Nirschl exercises in addition to myofascial release therapy in people with Lateral Epicondylitis, run by Riphah International 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 6 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: status not confirmed, as of the sponsor's last update on 10 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating scale (NPRS) (time frame: 10 months). 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?
On the ClinicalTrials.gov record for NCT05413967, which also lists 4 linked publications.
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 10 Jun 2022.