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Trial registered on ANZCTR


Registration number
ACTRN12616000590460
Ethics application status
Approved
Date submitted
23/03/2016
Date registered
6/05/2016
Date last updated
28/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Two methods of treatment of men with lumbar discopathy
Scientific title
Kaltenborn-Evjenth Manual Therapy in combination with Cryotherapy (KEOMT-C) versus Kaltenborn-Evjenth Manual Therapy in combination with Kinesiotaping (KEOMT-K) for treatment of men with lumbar discopathy: a randomised trial
Secondary ID [1] 288828 0
None
Universal Trial Number (UTN)
U1111-1181-1715
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 298106 0
Condition category
Condition code
Alternative and Complementary Medicine 298272 298272 0 0
Other alternative and complementary medicine
Musculoskeletal 298273 298273 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 298274 298274 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. KEOMT - by all participants [40 males, 10 treatments, 2 per week, for 5 weeks, duration - will last 45 min. KEOMT will include: lumbar segmental traction - supine position, lumbar segmental mobilization (flexion, extension, gliding therapy grade III), and soft tissue mobilization]. The physiotherapist will deliver the intervention.
Local cryotherapy - KEOMT-C [20 males, 10 treatments, 2 per week, for 5 weeks at the end of each session of manual therapy, duration - 3 minutes, application - paraspinal muscles on both sides of the lumbar spine up to the place of radiation pain. Local cryotherapy will be performed using KRIOPOL R30 (Kriomedpol, Poland). A stream of cold nitrogen vapor at temperature -130 degrees celsius will be applied to the paraspinal muscles on both sides of the lumbar spine up to the place of radiation pain. The distance among the apparatus nozzle and patients body surface - 10 centimeters. The physiotherapist will deliver the intervention].
Kinesiotaping - KEOMT-K [20 males, 10 treatments, 2 per week, for 5 weeks at the end of each session (after manual therapy), application - the place of pain. The group will receive taping with 2 strips (15 cm – length x 5 cm – width; Kinesio Registered Trademark Tex Gold). Duration - 20 minutes. The physiotherapist will deliver the intervention].
2. The location - Physiotherapy department. Once a week for 5 weeks - sessions will be administered.
3. Post isometric relaxation (PIR) - a part of KEOMT - both groups. PIR - quadratus lumborum and erector spinae muscles. PIR rules: 1. Bring the muscle to its maximum length without stretching, taking up the slack. There should be only minimal or no pain. 2. The patient is asked to resist with only minimal force (isometrically) and to breathe in for 10 seconds. 3. The patient is then told to ,,let go" (relax) and exhale slowly. It is important for the physiotherapist to wait and feel the relaxation. The physiotherapis could wait 10 to 20 seconds or longer as long as relaxation is taking place. Due to pure relaxation there should be an increase in the range of motion. 4. If the patient has difficulty relaxing, hold the isometric phase for 30 seconds before having the patient ,,let go." 5. Usually three to five times is all that is necessary to obtain spontaneous stretch each session. 6. Along with the breathing, having the patient look up (eyes only). This helps facilitate the inspiration, which facilitates the muscle. Have the patient look down during expiration to aid in relaxation.
The independent resercher will assess the scores of treatment.
Intervention code [1] 294283 0
Rehabilitation
Comparator / control treatment
KEOMT-K - control group.
Control group
Active

Outcomes
Primary outcome [1] 297759 0
low back pain using a 10 cm Visual Analogue Scale (VAS),and Laitinen scale
Timepoint [1] 297759 0
baseline, post-intervention (immediately)
Secondary outcome [1] 322147 0
quality of life (QOL) using short form-36 questionnaire (SF-36)
Timepoint [1] 322147 0
baseline, post-intervention (immediately)

Eligibility
Key inclusion criteria
minimum age of 30 years, men diagnosed with Magnetic Resonance Imaging (MRI) scan on the lumbar disc disease, pain associated with disc disease (failure of the intervertebral disc and herniated of disc), pain radiating to the extremities associated with compression and irritation of the nerve roots (inflammation of the nerve roots)
Minimum age
30 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
osteoporosis, untreated hypertension, heart failure, coronary artery disease, advanced atherosclerosis, chilblains, hypothyroidism, blood disorders, cancer, hypersensitivity to cold, skin changes, depression and other mental illness, inflammation (ankylosing spondylitis, rheumatoid arthritis), spine injuries (subluxation in intervertebral joints, spondylosis, spinal compression fractures, vertebral transverse process fractures), congenital and acquired disorders of statics of the spine (scoliosis, spondylolisthesis, sacralization of L5, lumblization of S1, spina bifida)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be concealed from the researchers enrolling and assessing participants in sequentially numbered opaque, sealed and stapled envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individuals who consent to take part in the study and fulfill all inclusion and exclusion criteria will be assigned on 1:1 ratio using a simple random number table into two treatment groups: a KEOMT-C group and a KEOMT-K one.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7731 0
Poland
State/province [1] 7731 0
Silesia

Funding & Sponsors
Funding source category [1] 293190 0
University
Name [1] 293190 0
Holycross College
Address [1] 293190 0
51, Mielczarskiego Str.
25-709 Kielce
Country [1] 293190 0
Poland
Primary sponsor type
University
Name
Holycross College
Address
51, Mielczarskiego Str.
25-709 Kielce
Country
Poland
Secondary sponsor category [1] 291987 0
None
Name [1] 291987 0
Address [1] 291987 0
Country [1] 291987 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294676 0
The Holycross College Ethics Committee
Ethics committee address [1] 294676 0
51, Mielczarskiego Str.
25-709 Kielce
Ethics committee country [1] 294676 0
Poland
Date submitted for ethics approval [1] 294676 0
07/03/2016
Approval date [1] 294676 0
17/03/2016
Ethics approval number [1] 294676 0
04/172016KB

Summary
Brief summary
Lumbar discopathy is one of the main reasons for disability of the people in high, middle and low-income countries. Numerous modalities of therapeutic interventions are available for treatment of lumbar discopathy: manipulation, physical therapy, drugs, behavior therapy, and neural blockade. In cases resistant to conservative treatment, surgical treatment is used. Despite numerous studies, there are controversial opinions on the treatment of lumbar discopathy. Therefore, the objective of this study is to compare the efficiency of KEOMT-C versus KEOMT-K for the treatment of lumbar disc herniation. In present study we have taken hypothesis that KEOMT-C and KEOMT-K reduce the pain, improve the quality of life (QOL) as well as one of them more effectively treats lumbar discopathy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64566 0
Ms Wojciech Kobza
Address 64566 0
Bielski College named after Tyszkiewicz
12, Nabrzezna Str.
43-300 Bielsko-Biala
Country 64566 0
Poland
Phone 64566 0
+48 695 951 456
Fax 64566 0
Email 64566 0
centrumkosmetyki@gazeta.pl
Contact person for public queries
Name 64567 0
Dr Pawel Lizis
Address 64567 0
Holycross College
51, Mielczarskiego Str.
25-709 Kielce
Country 64567 0
Poland
Phone 64567 0
+48663793834
Fax 64567 0
Email 64567 0
pawel_lizis@poczta.onet.pl
Contact person for scientific queries
Name 64568 0
Dr Pawel Lizis
Address 64568 0
Holycross College
51, Mielczarskiego Str.
25-709 Kielce
Country 64568 0
Poland
Phone 64568 0
+48663793834
Fax 64568 0
Email 64568 0
pawel_lizis@poczta.onet.pl

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary