Relationship Between Pressure Pain Threshold and Pain Intensity, Affect and Disability in CLBP

NCT04482075 | Completed

• 1 other identifier: 00002
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The association between pressure pain threshold and different aspects of low back pain has garnered attention over the years. However, since most of such studies in the past employed cross sectional designs, a longitudinal study design with follow-up measurements is required to further investigate this relationship. Studying this relationship will not only offer insights into the phenomenon of pain but may also bring us one step closer to achieving the seemingly insurmountable goal of objectively measuring back pain and its different dimensions.

Conditions

Pain Threshold; Low Back Pain; Pain Measurement

Outcome Measures

Primary Outcomes (4)

• Pressure threshold meter

  Its a type of force gauge which consists of a rubber-tipped plunger with a surface area of usually 1cm square, connected to the force gauge (body) via a metal rod. The force gauge is usually calibrated in Newtons or Kilograms per cm2 with a range of up to 10 kgs. The exerted pressure on the plunger is transmitted to the gauge through the metal rod, which in turn moves the indicator needle in the clockwise direction with a magnitude corresponding to the force applied. The indicator needle remains in this position until the zeroing knob is pressed, which brings the needle back to its starting position. This allows the examiner to record the last reading of the pressure applied after removing the device from the body.

  Up to 2 weeks

• Visual Analogue scale (VAS) - pain intensity

  Visual Analogue scale furnished with specific anchors to measure pain intensity. It is a continuous scale that is considered as a unidimensional measure of the pain experience. It consists of a 100 mm straight line, anchored by descriptors such as 'no pain at all' (0mm) and 'worst pain imaginable' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete. VAS demonstrates ratio-scale properties and it can be adapted to assess dimensions other than intensity such as unpleasantness (affective dimension) associated with pain.

  Up to 2 weeks

• Visual Analogue scale (VAS) - pain affect

  Visual analogue scale fine-tuned to measure pain affect with specific anchors. In general, the same technique used for assessing the pain intensity may be used to assess the pain affect. It consists of a 100 mm straight line, anchored by descriptors such as ''not bad at all'' (0mm) and ''the most unpleasant feeling possible for me'' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete.

  Up to 2 weeks

• Disability Rating Index (DRI)

  This article focuses on the Disability Rating Index (DRI), a patient-reported outcome measure developed by Salén et al. in 1994, with the aim of measuring the physical disability of respondents within a clinical setting. The DRI evaluates a respondent's disability by assessing activity and participation limitations. It covers 12 non-specific activities of daily life, each one self-rated on a visual analogue scale of 0-100 mm, providing a score of 0-100 for each activity, where 0 represents no difficulty in performing the specific task and 100 indicates an inability to perform the task at all.

  Up to 2 weeks

Secondary Outcomes (2)

• Saltin-Grimby Physical Activity Level Scale (SGPALS)

  At baseline

• Depression, Anxiety and Stress Scale (DASS-21)

  Up to 2 weeks

Study Arms (1)

SEGMENTAL STABILISATION TRAINING (SST)

OTHER

Segmental Stabilisation Training is an established treatment technique for chronic low back pain

Other: segmental stability training

Interventions

segmental stability training OTHER

SEGMENTAL STABILISATION TRAINING (SST): This part of the therapy shall involve Isometric co-contraction of Lumbar Transversus abdominis and Lumbar Multifidus. The patient shall perform 10 repetitions of abdominal drawing-in manoeuvre with 30-40% Maximal Voluntary Contraction (MVC) with a 10-second hold in specific prescribed positions.

SEGMENTAL STABILISATION TRAINING (SST)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Adult males with low back pain with an age group of 18-50 years.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult males with low back pain with an age group of 18-50 years.

You may not qualify if:

• Individuals having low back pain for less than 3 months.
• Individuals with specific underlying pathology as the cause of CLBP. (Active oncological disease, Known disc derangement, cauda equina syndrome, spinal trauma i.e. fracture, neuropathy i.e. sciatica or severe root compression, spinal structural deformity, infection, inflammatory joint disease, spinal stenosis, spondylolysis, spondylolisthesis).
• Individuals having neurological diseases (including central and peripheral diseases); metabolic diseases (i.e. diabetes and hypothyroidism); coagulopathies (i.e. haemophilia).
• Individuals with fibromyalgia syndrome (FMS); myofascial pain syndrome (MPS); allodynia (stroking hyperalgesia).
• Individuals suffering from aphasia or suffering from deafness, blindness or muteness.
• Individuals with skin disease (i.e. psoriasis, scleroderma, leprosy, etc.) or skin lesions (i.e. abrasion/laceration/ bruise) in the low back region.
• Individuals having oral temperature of 100 F or above.
• Individuals who have undergone spinal surgery.
• Individuals scoring 28+ for depression, 20+ for anxiety, 34+ for stress on DASS-21.
• Individuals in whom prone lying causes significant discomfort (i.e. dyspnoea etc.).
• Individuals who do not perceive pressure pain below 10 kg/cm2 during PPT testing.
• Individuals evincing bruising to PPT testing.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Institute of Physical medicine & Rehabilitation, Dow University of Health Sciences

Karachi, Sindh, Pakistan

Location

Related Publications (1)

• Ul Hasanat R, Syed SA, Rathore FA, Iftikhar S. Development of a tool for objectively measuring somatic pain in the low back region based on a longitudinal diagnostic study conducted in Karachi, Pakistan. BMJ Open. 2023 Mar 16;13(3):e067129. doi: 10.1136/bmjopen-2022-067129.

  PMID: 36927595 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rasim Ul Hasanat Qureshi, MSPT

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

• Shahzad Ali Syed, MSAPT

  Dow University of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: July 22, 2020
• Study Start: July 1, 2019
• Primary Completion: December 23, 2020
• Study Completion: January 16, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

PA (1)