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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000269 |
Receipt No. | R000000340 |
Scientific Title | Effect of Home Exercise for chronic Low Back Pain: A Randomized Controlled Trial |
Date of disclosure of the study information | 2005/10/28 |
Last modified on | 2005/10/28 |
Basic information | ||
Public title | Effect of Home Exercise for chronic Low Back Pain: A Randomized Controlled Trial | |
Acronym | Low back pain Exercise Therapy (LET) Study | |
Scientific Title | Effect of Home Exercise for chronic Low Back Pain: A Randomized Controlled Trial | |
Scientific Title:Acronym | Low back pain Exercise Therapy (LET) Study | |
Region |
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Condition | |||
Condition | chronic low back pain | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the effect of home-based exercise for chronic low back pain. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | Assessment of pain: VAS
Assessment of disability: JLEQ (Japan Low-back pain Evaluation Questionnaire) and RDQ (Roland Morris Disability Questionnaire) |
Key secondary outcomes | Assessment of impairment: Finger- floor distance |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment | Central registration |
Intervention | |||
No. of arms | 2 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | Exercise (E) group: After delivering a brochure on low back pain exercise medical professionals directly give a lecture of the exercise. The therapeutic exercise is performed as home exercise. At the same time, proper posture guidance is performed using the form | ||
Interventions/Control_2 | NSAID (N) group: non-steroidal anti-inflammatory drugs (NSAIDs) is prescribed. At the same time, proper posture guidance is performed using the form | ||
Interventions/Control_3 | |||
Interventions/Control_4 | |||
Interventions/Control_5 | |||
Interventions/Control_6 | |||
Interventions/Control_7 | |||
Interventions/Control_8 | |||
Interventions/Control_9 | |||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The patients satisfying the following conditions (1)-(4) are included.
(1) Outpatients aged 20-65 years old. Both men and women are able to join the trial. (2) Patients who have had low back pain lasting more than 3 months. The symptom is chronic and no obvious neurological deficit. A chronologic fluctuation of the pain is not considered if the pain itself continues more than 3 months. (3) Low back pain is defined as the back ache occurring between the L1 spinal process and the gluteal sulcus. (4) The patient satisfying the following conditions: 1. Leg raising angle (by SLR maneuver) is less than 70 degrees. 2. There is no sensory deterioration by a superficial sensory examination. 3. The muscle strength in the lower limb is more than 4 by the Manual Muscle Testing (MMT). 4. The FNST (femoral nerve stretch test) is negative. |
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Key exclusion criteria | (1) Patient who had operation for lumbar spine in the past.
(2) Patient who had spine/spinal cord neoplasm, infection, and fracture (compression fracture) (3) Patient who had severe osteoporosis (more than the III degree in the Jikei Med. Univ. classification) (4) Patient with psychiatric disorder. (5) Patient who had a history with cerebrovascular accident within 6 months before the day of agreement to enter the trial (6) Patient who had a history with myocardial infarction within 6 months before the day of agreement to enter the trial (7) Patient who received treatment for cardiac failure (8) Patient with liver dysfunction (9) Patient with renal dysfunction (10) Pregnant patient. |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | The Japanese Orthopaedic Association | ||||||
Division name | Chief Director | ||||||
Zip code | |||||||
Address | Hongou 2-40-8, Bunkyo-ku, Tokyo, JAPAN | ||||||
TEL | 03-3816-3671 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | National Rehabilitation Center for Persons with Disabilities | ||||||
Division name | Training Center | ||||||
Zip code | |||||||
Address | 4-1 Namiki, Tokorozawa, Saitama, JAPAN | ||||||
TEL | 04-2995-3100 | ||||||
Homepage URL | |||||||
iwaya@rehab.go.jp |
Sponsor | |
Institute | The Japanese Orthopaedic Association |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | The Japanese Clinical Orthopaedic Association
The Japanese Society for Musculoskeletal Rehabilitation |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
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Adverse events | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000340 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |