Referred PainNCT02560259
The Role of Referred Pain From the Retro Trochanteric Region in Patients With Knee Pain
A study testing Physiotherapy and Conservative treatment in people with Referred Pain, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The role of referred pain from the retro trochanteric region, in patients with knee pain. Defining and quantifying this sub group of knee patients in the investigators list of refered knee patients. Evaluating the effect of treatment. A randomized trial. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Referred Pain
- What is being tested?
- Physiotherapy and Conservative treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2015to Aug 2017
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Knee pain
- Failure to understand the pain with more conventional diagnosis
- Symptoms and retrotrochanteric pain with examination
- Pain relief with retro trochanteric local anaesthetic injection
Who cannot join
- Mental illness
- Failure to cooperate
- Not adequate Norwegian language skills
- Other well known disease explaining symptoms
Trial locations and contacts
1 site in 1 country.
Norway1 site
University Hospital of Northern Norway
Tromsø
Anders Hennig, Physician, +4797650807, anders.hennig@unn.no
Oddmund Johansen, Professor, +4707766, oddmund.johansen@unn.no
About this study
Official title: The Role of Referred Pain From the Retro Trochanteric Region in Patients With Knee Pain. Prevalence, Interpretation and Management: A Randomized Controlled Study
The role of referred pain from the retro trochanteric region, in patients with knee pain. Defining and quantifying this sub group of knee patients in the investigators list of refered knee patients. Evaluating the effect of treatment. A randomized trial.
Read the detailed description
Knee pain is a great problem in the society. Besides obvious and known causes, for which there are increasing understanding and ways to treat, there is still a rather large group of patients in which the symptoms are not easily understood and harder to treat.
This group is often characterized by having symptoms ranging from months to years, having seen several physicians, gone through several x-rays/mri´s, and various treatment with no help.
The investigators find ever more suspicion towards specific mechanisms in the hip region as a source of knee pain. It is well known in pediatric medicine that children with serious disease in the hip often debut with knee pain. This relationship is not so well established in adults.
Pain in the lower extremity can arise from inflammation or strain of the retro trochanteric muscles, and/or more indirectly if these processes impact the sciatic nerve. The later explanation is commonly known as the piriformis syndrome.
Professor Oddmund Johansen has studied this type of pain extensively. In the later years he has found interest in patients with knee pain.
These patients will often have pain with deep palpation to the posterior hip region, when tightening the hip rotators with flexion and adduction, and they will often respond with pain relief, within minutes, when local anesthesia is placed on the distal attachment of the hip rotators on the posterior margin of the greater trochanter. Afterwards, lasting pain relief can be seen with a specified stretching regiment for these muscles.
The investigators will recruit suiting patients from a knee referral list. Inclusion will be based on clinical examination and whether they respond to the injection. After inclusion they will be scored with pain and quality of life forms, randomised in two groups, one with a stretching regime and one with conservative and symptomatic treatment.
There is interest in defining and quantifying this sub group of knee patients. They will be followed up after 3 months, with a new examination and scoring to evaluate the effect of the intervention.
The study will examine how the patients react and comply with the proposed diagnosis and treatment. A cost analysis will also be considered.
- Conditions
- Referred Pain
- Being tested
- Physiotherapy, Conservative treatment
- Keywords
- knee pain
- Medical subject headings
- Pain, Referred
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Physiotherapy
Conservative treatmentOther
Conservative treatment
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy Group | Active comparator | Physiotherapy Receives: Other: Physiotherapy |
| Conservative group | Placebo comparator | Conservative treatment Receives: Other: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on VAS score
0 no pain, 10 worst possible pain
Measured: At 3 months
Secondary outcomes (5)
KOOS score subscales Pain
Standard scoring on the KOOS subscale of pain
Measured: At 3 months
KOOS score subscale Symptoms
Standard scoring on the KOOS subscale of symptoms
Measured: At 3 months
KOOS score subscale Function in daily living
Standard scoring on the KOOS subscale of Function of daily living
Measured: At 3 months
KOOS score subscale Knee-Related Quality of Life
Standard scoring on the KOOS subscale of Knee-Related Quality of Life
Measured: At 3 months
KOOS score subscale Function in Sports and Recreation
Standard scoring on the KOOS subscale of Function in Sports and Recreation
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2017 (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 Referred PainStudies 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oddmund Johansen, University Hospital of North Norway
- Investigators
- Oddmund Johansen, Professor, Principal investigator, University Hospital og North Nprway, ortopedic department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560259
- Sponsor's protocol ID
- 2015/157(REK)
- Status last verified
- Sep 2015
- First submitted
- 11 May 2015
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Meknas K, Kartus J, Letto JI, Flaten M, Johansen O. A 5-year prospective study of non-surgical treatment of retro-trochanteric pain. Knee Surg Sports Traumatol Arthrosc. 2009 Aug;17(8):996-1002. doi: 10.1007/s00167-009-0750-z. Epub 2009 Mar 5.
PubMed 19263036Meknas K, Johansen O, Kartus J. Retro-trochanteric sciatica-like pain: current concept. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1971-85. doi: 10.1007/s00167-011-1573-2. Epub 2011 Jun 16.
PubMed 21678093Meknas K, Kartus J, Letto JI, Christensen A, Johansen O. Surgical release of the internal obturator tendon for the treatment of retro-trochanteric pain syndrome: a prospective randomized study, with long-term follow-up. Knee Surg Sports Traumatol Arthrosc. 2009 Oct;17(10):1249-56. doi: 10.1007/s00167-009-0787-z. Epub 2009 Apr 18.
PubMed 19396428Meknas K, Christensen A, Johansen O. The internal obturator muscle may cause sciatic pain. Pain. 2003 Jul;104(1-2):375-80. doi: 10.1016/s0304-3959(03)00045-9.
PubMed 12855348
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Referred Pain From the Retro Trochanteric Region in Patients With Knee Pain. Prevalence, Interpretation and Management: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02560259
- Acronym / sponsor ID
- 2015/157(REK)
- Conditions
- Referred Pain
- Keywords
- knee pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 25 Sep 2015 (estimated)
- 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.
The role of referred pain from the retro trochanteric region, in patients with knee pain. Defining and quantifying this sub group of knee patients in the investigators list of refered knee patients. Evaluating the effect of treatment. A randomized trial.
Detailed description
Knee pain is a great problem in the society. Besides obvious and known causes, for which there are increasing understanding and ways to treat, there is still a rather large group of patients in which the symptoms are not easily understood and harder to treat.
This group is often characterized by having symptoms ranging from months to years, having seen several physicians, gone through several x-rays/mri´s, and various treatment with no help.
The investigators find ever more suspicion towards specific mechanisms in the hip region as a source of knee pain. It is well known in pediatric medicine that children with serious disease in the hip often debut with knee pain. This relationship is not so well established in adults.
Pain in the lower extremity can arise from inflammation or strain of the retro trochanteric muscles, and/or more indirectly if these processes impact the sciatic nerve. The later explanation is commonly known as the piriformis syndrome.
Professor Oddmund Johansen has studied this type of pain extensively. In the later years he has found interest in patients with knee pain.
These patients will often have pain with deep palpation to the posterior hip region, when tightening the hip rotators with flexion and adduction, and they will often respond with pain relief, within minutes, when local anesthesia is placed on the distal attachment of the hip rotators on the posterior margin of the greater trochanter. Afterwards, lasting pain relief can be seen with a specified stretching regiment for these muscles.
The investigators will recruit suiting patients from a knee referral list. Inclusion will be based on clinical examination and whether they respond to the injection. After inclusion they will be scored with pain and quality of life forms, randomised in two groups, one with a stretching regime and one with conservative and symptomatic treatment.
There is interest in defining and quantifying this sub group of knee patients. They will be followed up after 3 months, with a new examination and scoring to evaluate the effect of the intervention.
The study will examine how the patients react and comply with the proposed diagnosis and treatment. A cost analysis will also be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy Group | Active comparator | Other: PhysiotherapyPhysiotherapy |
| Conservative group | Placebo comparator | Other: Conservative treatmentConservative treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Knee pain
- Failure to understand the pain with more conventional diagnosis
- Symptoms and retrotrochanteric pain with examination
- Pain relief with retro trochanteric local anaesthetic injection
Key exclusion criteria (4 listed)
- Mental illness
- Failure to cooperate
- Not adequate Norwegian language skills
- Other well known disease explaining symptoms
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 |
|---|---|---|
| PhysiotherapyPhysiotherapy | Other | Physiotherapy Group |
| Conservative treatmentConservative treatment | Other | Conservative group |
Primary outcome
Pain on VAS score
Time frame: At 3 months
0 no pain, 10 worst possible pain
5 secondary outcomes
KOOS score subscales Pain
Time frame: At 3 months
KOOS score subscale Symptoms
Time frame: At 3 months
KOOS score subscale Function in daily living
Time frame: At 3 months
KOOS score subscale Knee-Related Quality of Life
Time frame: At 3 months
KOOS score subscale Function in Sports and Recreation
Time frame: At 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
- Results publication: PubMed 19263036Meknas K, Kartus J, Letto JI, Flaten M, Johansen O. A 5-year prospective study of non-surgical treatment of retro-trochanteric pain. Knee Surg Sports Traumatol Arthrosc. 2009 Aug;17(8):996-1002. doi: 10.1007/s00167-009-0750-z. Epub 2009 Mar 5.
- Results publication: PubMed 21678093Meknas K, Johansen O, Kartus J. Retro-trochanteric sciatica-like pain: current concept. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1971-85. doi: 10.1007/s00167-011-1573-2. Epub 2011 Jun 16.
- Results publication: PubMed 19396428Meknas K, Kartus J, Letto JI, Christensen A, Johansen O. Surgical release of the internal obturator tendon for the treatment of retro-trochanteric pain syndrome: a prospective randomized study, with long-term follow-up. Knee Surg Sports Traumatol Arthrosc. 2009 Oct;17(10):1249-56. doi: 10.1007/s00167-009-0787-z. Epub 2009 Apr 18.
- Results publication: PubMed 12855348Meknas K, Christensen A, Johansen O. The internal obturator muscle may cause sciatic pain. Pain. 2003 Jul;104(1-2):375-80. doi: 10.1016/s0304-3959(03)00045-9.
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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.
Oddmund Johansen, Professor principal investigator
University Hospital og North Nprway, ortopedic department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy and Conservative treatment in people with Referred Pain, run by University Hospital of North Norway at 1 site in Norway.
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 4 inclusion and 4 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 25 Sep 2015. 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 Norway. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anders Hennig, Physician (+4797650807, anders.hennig@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on VAS score (time frame: At 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 NCT02560259, 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 25 Sep 2015.