Meniscal DegenerationTeMPONCT03059004
Comparing Different Types of Physical Therapy for Treating People With a Meniscal Tear and Osteoarthritis
A study testing TeMPO Home Exercise Program, Motivational SMS Messages and In-Clinic Topical Therapy in people with Meniscal Degeneration and Osteoarthritis, Knee, run by Brigham and Women's Hospital at 4 sites in United States.
Trial summary
Knee osteoarthritis is a disabling problem affecting over 15 million adults in the United States. Many people who have knee arthritis also experience painful meniscal tears. There are a number of different treatments that can be used to manage meniscal tears in the presence of knee arthritis. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Meniscal Degeneration, Osteoarthritis, Knee
- What is being tested?
- TeMPO Home Exercise Program, Motivational SMS Messages and In-Clinic Topical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 879 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Feb 2018to 1 Dec 2024
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee pain of at least 21 days duration if traumatic; no minimum duration if non-traumatic
- Age 45 -85 years
- Physician diagnosis of meniscal tear
- Evidence on MRI of meniscal tear
- Evidence of osteoarthritic changes on imaging: Cartilage damage on MRI, osteophyte or joint space narrowing on X-ray
Who cannot join
- KL-Grade 4
- Inflammatory arthritis
- Prior APM or TKR on index knee; or any surgery on index knee in prior 6 mo
- Pregnancy
- Contraindication to MRI
- Daily use of strong opioids
Show all 11Show fewer
- Intra-articular therapy in last 4 weeks
- Non-English speaking
- History of dementia
- Currently resides in a nursing home
- Current claimant of worker's compensation for this condition
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University at Buffalo Medical Department
Buffalo, New York, 14215
Cleveland Clinic
Cleveland, Ohio, 44195
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15237
About this study
Official title: Treatment of Meniscal Problems in Osteoarthritis
Knee osteoarthritis is a disabling problem affecting over 15 million adults in the United States. Many people who have knee arthritis also experience painful meniscal tears. There are a number of different treatments that can be used to manage meniscal tears in the presence of knee arthritis. Treatments include surgically removing the damaged part of the meniscus; strengthening exercises to improve pain and function; manual therapy including massage and mobilization; acupuncture; and others. The combination of surgery and exercise therapy was long thought to be the best treatment. However, recent studies have shown that surgery followed by physical therapy is no more effective than physical therapy by itself.
While physical therapy alone has been shown to result in similar pain relief as arthroscopic surgery, researchers have not yet done studies to determine what type of physical therapy is best for people with knee arthritis and meniscal tears. In the "TeMPO" Trial, we will be comparing 4 different, non-operative physical therapy regimens in order to gain a better understanding of how physical therapy works and what regimen will best reduce pain and improve function in persons with meniscal tear and osteoarthritis. The four arms in this randomized trial will contain different combinations of therapeutic treatments including in-clinic therapist-supervised exercise, in-clinic topical therapies, and exercises to be completed at home. Subjects in three of the arms will also receive motivational SMS (text) messages intended to improve adherence to the home exercise regimen.
Read more
TeMPO is designed as a randomized controlled trial. Participants will be assigned randomly to one of the four arms. All arms include therapies that have been previously shown to work in clinical settings. One arm also contains some placebo treatments. The placebo treatments will help us to understand what aspects of physical therapy actually make people feel better.
Our hypothesis is that subjects in the arm that includes in-clinic physical therapy and a home exercise regimen will experience more pain relief than subjects in each of the other arms. Also, we expect that subjects in the arm that receives the home exercise regimen and SMS messages will experience more pain relief than subjects in the arm that receives home exercise without the SMS messages.
Read the detailed description
Knee osteoarthritis is a disabling problem affecting over 15 million adults in the United States. Many people who have knee arthritis also experience painful meniscal tears. There are a number of different treatments that can be used to address meniscal tears in the presence of knee arthritis. These include surgically removing the damaged part of the meniscus; strengthening exercises; manual therapy including massage and mobilization; and others. The combination of surgery and exercise therapy was long thought to be the best treatment. However, recent studies have shown that surgery followed by physical therapy leads to similar levels of pain relief as physical therapy alone.
While physical therapy appears to be useful in knee osteoarthritis and meniscal tear, research is needed to determine what type of physical therapy is best for people with these conditions. The "TeMPO" Trial will compare 4 different non-operative regimens in order to gain a better understanding of how physical therapy works and to determine which regimen will best reduce participants' pain and improve their function. The four arms in this trial will contain different combinations of therapeutic treatments including in-clinic supervised exercise therapy, in-clinic topical therapies, and exercises to be completed at home. Some of the arms will also receive text messages designed to improve adherence to assigned exercises. All arms include therapies that have been previously shown to work in clinical settings. One arm also contains some placebo treatments. The placebo treatments will help identify the aspects of physical therapy that make people feel better.
The four arms in the TeMPO study are as follows:
- Home Exercise Program
- Home Exercise Program + Motivational SMS messages
- Home Exercise Program + Motivational SMS messages + In-Clinic topical therapy
- Home Exercise Program + Motivational SMS messages + In-Clinic Exercise Therapy
- Conditions
- Meniscal Degeneration, Osteoarthritis, Knee
- Being tested
- TeMPO Home Exercise Program, Motivational SMS Messages, In-Clinic Topical Therapy, In-Clinic Exercise Therapy
- Keywords
- physical therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeMPO Home Exercise ProgramBehavioural
This exercise program includes quadriceps, gluteus medius, gluteus maximus, and core exercises. The program includes a DVD and multi-page instruction pamphlet.
Motivational SMS MessagesBehavioural
The motivational SMS messages will be sent three times per week encouraging participants to complete their exercises.
In-Clinic Topical TherapyBehavioural
Subjects will be assigned to a physical therapist and will attend 14 in-clinic topical therapy sessions. Sessions will include application of ultrasound, gel, and manual therapy.
In-Clinic Exercise TherapyBehavioural
Subjects will be assigned to a physical therapist and will attend 14 in-clinic exercise and manual therapy sessions. Sessions will include the same exercises from the Home Exercise Program but the in-clinic therapy setting will allow for more personalization.
| Study group | Role | What they receive |
|---|---|---|
| 1. Home Exercise Program | Experimental | The Home Exercise group receives the TeMPO Home Exercise Program (including a set of weights, a DVD showing how to complete the TeMPO exercises, and a pamphlet outlining instructions on how to complete the exercises and how often should they be done). Receives: Behavioral: TeMPO Home Exercise Program |
| 2. Home Exercise Program + SMS Messages | Experimental | Subjects in this arm receive the TeMPO Home Exercise Program and motivational SMS messages to encourage them to adhere to the TeMPO Home Exercise regimen. Receives: Behavioral: TeMPO Home Exercise Program; Behavioral: Motivational SMS Messages |
| 3. In-Clinic Topical Therapy | Experimental | Subjects in this arm receive the TeMPO Home Exercise Program, motivational SMS messages to encourage them to adhere to the TeMPO Home Exercise Program, and 14 in-clinic sessions with a trained physical therapist. The therapist will apply topical therapies: ultrasound, gel, and manual therapy. Receives: Behavioral: TeMPO Home Exercise Program; Behavioral: Motivational SMS Messages; Behavioral: In-Clinic Topical Therapy |
| 4. In-Clinic Exercise Therapy | Experimental | Subjects in this arm will receive the TeMPO Home Exercise Program, SMS motivational messages to encourage them to adhere to the TeMPO Home Exercise Program and 14 in-clinic sessions with a trained physical therapist. The therapist will supervise the participant in a rigorous set of strengthening and stretching exercises. Receives: Behavioral: TeMPO Home Exercise Program; Behavioral: Motivational SMS Messages; Behavioral: In-Clinic Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain
Difference between arms in change in the KOOS Pain score over three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1. Arm 4 vs. Arm 3)
Measured: Randomization to 3 months
Secondary outcomes (8)
Change in function
Difference between arms in change in the KOOS ADL score over three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3)
Measured: Randomization to 3 months
Change in quality of life
Difference between arms in change in quality of life measured with the EQ-5D scale over three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3)
Measured: Randomization to 3 months
Binary treatment failure indicator
Difference between arms in treatment failure defined as either not reaching improvement of >=8 points on KOOS Pain or receiving injection or undergoing index knee surgery within three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3)
Measured: Randomization to 3 months
Forty meter fast-paced walk
Difference between arms in change in 40 m fast-paced walk (seconds) over three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3)
Measured: Randomization to 3 months
30-second sit to stand
Difference between arms in number of repetitions (of sit to stand) over 30 seconds
Measured: Randomization to 3 months
Strength of quadriceps, hamstrings, gluteus medius
Difference between arms in strength (pounds-cm) between arms, measured at three sites (quadriceps, hamstrings, gluteus medius)
Measured: Baseline to 3 months
Single Leg Balance
Difference between arms in number of seconds participant can stand on single leg without moving hands off hips, stepping or stumbling, abducting or flexing hip beyond 30 deg, lifting heel or forefoot off ground.
Measured: Baseline to 3 months
Durability of pain relief
Difference between arms in proportion of subjects who maintain through 12 months the benefit (in KOOS Pain) achieved at 3 months. (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1; Arm 4 vs. Arm 3 )
Measured: 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start6 Feb 2018
- Primary completion1 Oct 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Meniscal DegenerationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Parallel groups
- Model description
- Four arm parallel randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 879 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), State University of New York at Buffalo, The Cleveland Clinic, University of Pittsburgh, University of Melbourne, Boston University
- Responsible party
- Principal investigator, Jeffrey Neil Katz, MD, Brigham and Women's Hospital
- Investigators
- Chuck Washabaugh, PhD, Study chair, National Institute for Arthritis, Musculoskeletal and Skin Diseases (NIAMS, NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059004
- Sponsor's protocol ID
- 1U01AR071658-01
- Acronym
- TeMPO
- Status last verified
- Jun 2025
- First submitted
- 14 Feb 2017
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request to jnkatz@bwh.harvard.edu we will share core baseline and primary outcome data 12 months after primary report is published. Request must include hypotheses, analytic plans, rationale.
Publications
Katz JN, Collins JE, Bisson L, Jones MH, Irrgang JJ, Selzer F, Safran-Norton CE, Spindler KP, Yang HY, Shrestha S, Bennell KL, Sullivan JK, Kluczynski MA, Arant K, Opare-Addo M, Huizinga JL, Zimmerman Z, Sople D, Tonsoline P, Kale M, Wind WM Jr, Chen AF, Freitas M, Lesniak B, Jordan K, Matzkin EG, Dawson C, Farrow L, Musahl V, Leddy JJ, Martin SD, Losina E. A Randomized Trial of Physical Therapy for Meniscal Tear and Knee Pain. N Engl J Med. 2025 Oct 30;393(17):1694-1703. doi: 10.1056/NEJMoa2503385.
PubMed 41160820Safran-Norton CE, Sullivan JK, Irrgang JJ, Kerman HM, Bennell KL, Calabrese G, Dechaves L, Deluca B, Gil AB, Kale M, Luc-Harkey B, Selzer F, Sople D, Tonsoline P, Losina E, Katz JN. A consensus-based process identifying physical therapy and exercise treatments for patients with degenerative meniscal tears and knee OA: the TeMPO physical therapy interventions and home exercise program. BMC Musculoskelet Disord. 2019 Nov 4;20(1):514. doi: 10.1186/s12891-019-2872-x.
PubMed 31684921Sullivan JK, Irrgang JJ, Losina E, Safran-Norton C, Collins J, Shrestha S, Selzer F, Bennell K, Bisson L, Chen AT, Dawson CK, Gil AB, Jones MH, Kluczynski MA, Lafferty K, Lange J, Lape EC, Leddy J, Mares AV, Spindler K, Turczyk J, Katz JN. The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial. BMC Musculoskelet Disord. 2018 Dec 1;19(1):429. doi: 10.1186/s12891-018-2327-9.
PubMed 30501629
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Meniscal Problems in Osteoarthritis
- ClinicalTrials.gov ID
- NCT03059004
- Acronym / sponsor ID
- TeMPO / 1U01AR071658-01
- Conditions
- Meniscal Degeneration, Osteoarthritis, Knee
- Keywords
- physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 879 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), State University of New York at Buffalo, The Cleveland Clinic, University of Pittsburgh, University of Melbourne, Boston University
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 23 Feb 2017 (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.
Knee osteoarthritis is a disabling problem affecting over 15 million adults in the United States. Many people who have knee arthritis also experience painful meniscal tears. There are a number of different treatments that can be used to manage meniscal tears in the presence of knee arthritis. Treatments include surgically removing the damaged part of the meniscus; strengthening exercises to improve pain and function; manual therapy including massage and mobilization; acupuncture; and others. The combination of surgery and exercise therapy was long thought to be the best treatment. However, recent studies have shown that surgery followed by physical therapy is no more effective than physical therapy by itself.
While physical therapy alone has been shown to result in similar pain relief as arthroscopic surgery, researchers have not yet done studies to determine what type of physical therapy is best for people with knee arthritis and meniscal tears. In the "TeMPO" Trial, we will be comparing 4 different, non-operative physical therapy regimens in order to gain a better understanding of how physical therapy works and what regimen will best reduce pain and improve function in persons with meniscal tear and osteoarthritis. The four arms in this randomized trial will contain different combinations of therapeutic treatments including in-clinic therapist-supervised exercise, in-clinic topical therapies, and exercises to be completed at home. Subjects in three of the arms will also receive motivational SMS (text) messages intended to improve adherence to the home exercise regimen.
TeMPO is designed as a randomized controlled trial. Participants will be assigned randomly to one of the four arms. All arms include therapies that have been previously shown to work in clinical settings. One arm also contains some placebo treatments. The placebo treatments will help us to understand what aspects of physical therapy actually make people feel better.
Our hypothesis is that subjects in the arm that includes in-clinic physical therapy and a home exercise regimen will experience more pain relief than subjects in each of the other arms. Also, we expect that subjects in the arm that receives the home exercise regimen and SMS messages will experience more pain relief than subjects in the arm that receives home exercise without the SMS messages.
Detailed description
Knee osteoarthritis is a disabling problem affecting over 15 million adults in the United States. Many people who have knee arthritis also experience painful meniscal tears. There are a number of different treatments that can be used to address meniscal tears in the presence of knee arthritis. These include surgically removing the damaged part of the meniscus; strengthening exercises; manual therapy including massage and mobilization; and others. The combination of surgery and exercise therapy was long thought to be the best treatment. However, recent studies have shown that surgery followed by physical therapy leads to similar levels of pain relief as physical therapy alone.
While physical therapy appears to be useful in knee osteoarthritis and meniscal tear, research is needed to determine what type of physical therapy is best for people with these conditions. The "TeMPO" Trial will compare 4 different non-operative regimens in order to gain a better understanding of how physical therapy works and to determine which regimen will best reduce participants' pain and improve their function. The four arms in this trial will contain different combinations of therapeutic treatments including in-clinic supervised exercise therapy, in-clinic topical therapies, and exercises to be completed at home. Some of the arms will also receive text messages designed to improve adherence to assigned exercises. All arms include therapies that have been previously shown to work in clinical settings. One arm also contains some placebo treatments. The placebo treatments will help identify the aspects of physical therapy that make people feel better.
The four arms in the TeMPO study are as follows:
- Home Exercise Program
- Home Exercise Program + Motivational SMS messages
- Home Exercise Program + Motivational SMS messages + In-Clinic topical therapy
- Home Exercise Program + Motivational SMS messages + In-Clinic Exercise Therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Four arm parallel randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| 1. Home Exercise Program | Experimental | Behavioral: TeMPO Home Exercise ProgramThe Home Exercise group receives the TeMPO Home Exercise Program (including a set of weights, a DVD showing how to complete the TeMPO exercises, and a pamphlet outlining instructions on how to complete the exercises and how often should they be done). |
| 2. Home Exercise Program + SMS Messages | Experimental | Behavioral: TeMPO Home Exercise Program, Behavioral: Motivational SMS MessagesSubjects in this arm receive the TeMPO Home Exercise Program and motivational SMS messages to encourage them to adhere to the TeMPO Home Exercise regimen. |
| 3. In-Clinic Topical Therapy | Experimental | Behavioral: TeMPO Home Exercise Program, Behavioral: Motivational SMS Messages, Behavioral: In-Clinic Topical TherapySubjects in this arm receive the TeMPO Home Exercise Program, motivational SMS messages to encourage them to adhere to the TeMPO Home Exercise Program, and 14 in-clinic sessions with a trained physical therapist. The therapist will apply topical therapies: ultrasound, gel, and manual therapy. |
| 4. In-Clinic Exercise Therapy | Experimental | Behavioral: TeMPO Home Exercise Program, Behavioral: Motivational SMS Messages, Behavioral: In-Clinic Exercise TherapySubjects in this arm will receive the TeMPO Home Exercise Program, SMS motivational messages to encourage them to adhere to the TeMPO Home Exercise Program and 14 in-clinic sessions with a trained physical therapist. The therapist will supervise the participant in a rigorous set of strengthening and stretching exercises. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Knee pain of at least 21 days duration if traumatic; no minimum duration if non-traumatic
- Age 45 -85 years
- Physician diagnosis of meniscal tear
- Evidence on MRI of meniscal tear
- Evidence of osteoarthritic changes on imaging: Cartilage damage on MRI, osteophyte or joint space narrowing on X-ray
Key exclusion criteria (11 listed)
- KL-Grade 4
- Inflammatory arthritis
- Prior APM or TKR on index knee; or any surgery on index knee in prior 6 mo
- Pregnancy
- Contraindication to MRI
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 |
|---|---|---|
| TeMPO Home Exercise ProgramThis exercise program includes quadriceps, gluteus medius, gluteus maximus, and core exercises. The program includes a DVD and multi-page instruction pamphlet. | Behavioural | 1. Home Exercise Program, 2. Home Exercise Program + SMS Messages, 3. In-Clinic Topical Therapy, 4. In-Clinic Exercise Therapy |
| Motivational SMS MessagesThe motivational SMS messages will be sent three times per week encouraging participants to complete their exercises. | Behavioural | 2. Home Exercise Program + SMS Messages, 3. In-Clinic Topical Therapy, 4. In-Clinic Exercise Therapy |
| In-Clinic Topical TherapySubjects will be assigned to a physical therapist and will attend 14 in-clinic topical therapy sessions. Sessions will include application of ultrasound, gel, and manual therapy. | Behavioural | 3. In-Clinic Topical Therapy |
| In-Clinic Exercise TherapySubjects will be assigned to a physical therapist and will attend 14 in-clinic exercise and manual therapy sessions. Sessions will include the same exercises from the Home Exercise Program but the in-clinic therapy setting will allow for more personalization. | Behavioural | 4. In-Clinic Exercise Therapy |
Primary outcome
Change in Pain
Time frame: Randomization to 3 months
Difference between arms in change in the KOOS Pain score over three months (Arm 4 vs. Arm 1; Arm 4 vs. Arm 2; Arm 2 vs. Arm 1. Arm 4 vs. Arm 3)
8 secondary outcomes
Change in function
Time frame: Randomization to 3 months
Change in quality of life
Time frame: Randomization to 3 months
Binary treatment failure indicator
Time frame: Randomization to 3 months
Forty meter fast-paced walk
Time frame: Randomization to 3 months
30-second sit to stand
Time frame: Randomization to 3 months
Strength of quadriceps, hamstrings, gluteus medius
Time frame: Baseline to 3 months
Single Leg Balance
Time frame: Baseline to 3 months
Durability of pain relief
Time frame: 3-12 months
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 Jul 2025.
- Derived from this study: PubMed 41160820Katz JN, Collins JE, Bisson L, Jones MH, Irrgang JJ, Selzer F, Safran-Norton CE, Spindler KP, Yang HY, Shrestha S, Bennell KL, Sullivan JK, Kluczynski MA, Arant K, Opare-Addo M, Huizinga JL, Zimmerman Z, Sople D, Tonsoline P, Kale M, Wind WM Jr, Chen AF, Freitas M, Lesniak B, Jordan K, Matzkin EG, Dawson C, Farrow L, Musahl V, Leddy JJ, Martin SD, Losina E. A Randomized Trial of Physical Therapy for Meniscal Tear and Knee Pain. N Engl J Med. 2025 Oct 30;393(17):1694-1703. doi: 10.1056/NEJMoa2503385.
- Derived from this study: PubMed 31684921Safran-Norton CE, Sullivan JK, Irrgang JJ, Kerman HM, Bennell KL, Calabrese G, Dechaves L, Deluca B, Gil AB, Kale M, Luc-Harkey B, Selzer F, Sople D, Tonsoline P, Losina E, Katz JN. A consensus-based process identifying physical therapy and exercise treatments for patients with degenerative meniscal tears and knee OA: the TeMPO physical therapy interventions and home exercise program. BMC Musculoskelet Disord. 2019 Nov 4;20(1):514. doi: 10.1186/s12891-019-2872-x.
- Derived from this study: PubMed 30501629Sullivan JK, Irrgang JJ, Losina E, Safran-Norton C, Collins J, Shrestha S, Selzer F, Bennell K, Bisson L, Chen AT, Dawson CK, Gil AB, Jones MH, Kluczynski MA, Lafferty K, Lange J, Lape EC, Leddy J, Mares AV, Spindler K, Turczyk J, Katz JN. The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial. BMC Musculoskelet Disord. 2018 Dec 1;19(1):429. doi: 10.1186/s12891-018-2327-9.
- Individual participant dataSharing planned: Yes. Upon request to jnkatz@bwh.harvard.edu we will share core baseline and primary outcome data 12 months after primary report is published. Request must include hypotheses, analytic plans, rationale.
Related trials for Meniscal Degeneration
RecruitingPhase 3
Meniscal INfiltration of Corticosteroid Guided With Ultra Sonography
Meniscus Lesion
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.
Chuck Washabaugh, PhD study chair
National Institute for Arthritis, Musculoskeletal and Skin Diseases (NIAMS, NIH)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeMPO Home Exercise Program, Motivational SMS Messages and In-Clinic Topical Therapy in people with Meniscal Degeneration and Osteoarthritis, Knee, run by Brigham and Women's Hospital at 4 sites in United States.
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 11 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 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Change in Pain (time frame: Randomization to 3 months). 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 NCT03059004, which also lists 3 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 3 Jul 2025.