Dry Needlig Vesus Tecartherapy in Low-back Pain Treatment
ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Alcala
About this trial
Introduction: Diathermy is a new tool that could help subjects with chronic low back pain (CLBP), with no studies having compared it to other interventions already investigated such as dry needling.
Hypothesis: Diathermy is more effective than dry needling in improving pain intensity in the short term in subjects with CLBP.
Design: randomised controlled trial Methods: We will conduct a convenience sampling, with subjects receiving 2 treatment sessions with diathermy or dry needling, according to allocation. Subjects will be assessed at baseline, 1 week, 1 month and 3 months after treatment for pain intensity, disability, kinesiophobia and catastrophizing. Analysis of variance (ANOVA) and moderation analysis will be performed to evaluate the results, with 95% confidence intervals (CI).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65 years.
Chronic non-specific low back pain.
Duration of pain of more than 6 weeks.
Disqualifiers
Neurological signs or symptoms.
Radicular pain.
Radiating pain below the knee.
Belonephobia.
Trial design
Design model
Parallel
Treatments tested in this trial
Dry needling
Other interventionInvasive treatment will be performed on the most symptomatic lumbar iliocostalis muscle.
Tecartherapy treatment
Other interventionTreatment will be carried out with deep thermotherapy in the lumbar region.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Dry needlingExperimental treatment 1 intervention
Group B: Diathermy treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Visual analogue scale
The visual analogue scale (VAS) is a 10cm long line where 0 indicates no pain at all and 10 the worst pain imaginable. It is a tool that has shown good reliability values (r = 0.94).
Time frame
Change from baseline at 3 monthsSecondary outcomes
1
Rolland-Morris questionnaire
The questionnaire scores from 0 (no disability) to 24 (maximum degree of disability), its cross-cultural adaptation to Spanish has shown good concurrent validity values (r = 0.34-0.57) and good reliability values (Intraclass Correlation Coefficient = 0.87).
Time frame
Change from baseline at 3 months2
Tampa Scale for Kinesiophobia 11 (TSK-11)
The questionnaire is scored from 11 to 44, the score being represented as a percentage from 0% (minimum degree of kinesiophobia) to 100% (maximum degree of kinesiophobia). The cross-cultural adaptation of the TSK-11 to Spanish has shown good concurrent validity values (r = 0.27-0.49) and good reliability values (r = 0.55).
Time frame
Change from baseline at 3 months3
Pain Catastrophism Scale
The questionnaire is scored from 0 to 54 and is represented as a percentage from 0% (minimum degree of catastrophism) to 100% (maximum degree of catastrophism). The cross-cultural adaptation to Spanish has shown good values of concurrent validity (r = 0.28-0.66) and reliability (Intraclass Correlation Coefficient = 0.84).
Time frame
Change from baseline at 3 months4
Pressure pain threshold
The pressure pain threshold (PPT) will be measured using a hand-held algometer (Wagner Force Dial, Model FDK 20, Wargner Instruments, Greenwich, CT, USA). This algometer has a 1cm2 surface area tip that records the pressure in kg/cm2. The algometer has been shown to be a valid and reliable tool for the measurement of UDP, with Intraclass Correlation Coefficient values in subjects with low back pain of 0.93.
Time frame
Change from baseline at 3 monthsSponsors and contacts
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Source ClinicalTrials.gov