Exploring Massage Benefits for Arthritis of the Knee (EMBARK)

• Change in Pain: The Visual Analog Scale (VAS) [ Time Frame: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group) ] [ Designated as safety issue: No ]
  Used to measure pain sensation intensity evoked by nociceptive stimuli. Subjects quickly and easily rate stimuli within the series by indicating level of pain on a 100 mm scale. Pain intensity is represented by the participant drawing a line on the scale indicative of pain experienced (0 = no pain, to 100 = worse pain imaginable). The VAS is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable."
• Change in Pain: PROMIS Pain Interference Questionnaire [ Time Frame: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group) ] [ Designated as safety issue: No ]
  Patient Reported Outcomes Measurement Information System (PROMIS), funded by the National Institutes of Health (NIH), is a system of highly reliable, valid, flexible, precise, and responsive assessment tools that measure patient-reported health status. The Pain Interference Questionnaire has 6 questions answered on an ordinal scale of five gradations.
• Change in Joint Flexibility [ Time Frame: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group) ] [ Designated as safety issue: No ]
  Joint flexibility is defined as the range of motion (ROM) allowed at the knee. The knee's ROM is measured by the number of degrees from the starting position of a segment to its position at the end of its full range of the movement. This is measured using a double-armed goniometer. A stationary arm holding a protractor is placed parallel with a stationary body segment and a movable arm moves along a moveable body segment. The pin (axis of goniometer) is placed over the joint.
• Change in Physical Function [ Time Frame: Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group) ] [ Designated as safety issue: No ]
  Measured time in seconds to walk fifty (50) feet (15 m) on a level surface within the clinic facilities.

• Pain: The Visual Analog Scale (VAS) [ Time Frame: Baseline, 8, 16, 24, 36, and 52 weeks. ] [ Designated as safety issue: No ]
  Used to measure pain sensation intensity evoked by nociceptive stimuli. Subjects quickly and easily rate stimuli within the series by indicating level of pain on a 100 mm scale. Pain intensity is represented by the participant drawing a line on the scale indicative of pain experienced (0 = no pain, to 100 = worse pain imaginable). The VAS is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable."
• Pain: PROMIS Pain Interference Questionnaire [ Time Frame: Baseline, 8, 16, 24, 36, and 52 weeks. ] [ Designated as safety issue: No ]
  Patient Reported Outcomes Measurement Information System (PROMIS), funded by the National Institutes of Health (NIH), is a system of highly reliable, valid, flexible, precise, and responsive assessment tools that measure patient-reported health status. The Pain Interference Questionnaire has 6 questions answered on an ordinal scale of five gradations.
• Joint Flexibility [ Time Frame: Baseline, 8, 16, 24, 36 and 52 weeks. ] [ Designated as safety issue: No ]
  Joint flexibility is defined as the range of motion (ROM) allowed at the knee. The knee's ROM is measured by the number of degrees from the starting position of a segment to its position at the end of its full range of the movement. This is measured using a double-armed goniometer. A stationary arm holding a protractor is placed parallel with a stationary body segment and a movable arm moves along a moveable body segment. The pin (axis of goniometer) is placed over the joint.
• Physical Function [ Time Frame: Baseline, 8, 16, 24, 36, and 52 weeks. ] [ Designated as safety issue: No ]
  Measured time in seconds to walk fifty (50) feet (15 m) on a level surface within the clinic facilities.

The purpose of this study is to verify the efficacy of an 8-week course of manualized Swedish massage for reducing pain and increasing function compared to light-touch bodywork, and usual care, in 222 adults with OA of the knee.

• Experimental: Swedish Massage
  Swedish massage for one hour, once per week, for eight weeks. At week 10, 50% of patients will be randomized to a maintenance dose (one hour of Swedish massage every two weeks), and 50% will be randomized to Usual Care.
  Intervention: Procedure: Massage Therapy
• Active Comparator: Light Touch Bodywork
  Light-touch bodywork for one hour, once per week, for eight weeks. At week 10, 50% of the patients will be randomized to a maintenance dose (one hour of light-touch massage every two weeks, and 50% will be randomized to Usual Care.
  Intervention: Procedure: Massage Therapy
• Usual Care
  Those initially randomized to the usual care control will be rolled into the Swedish massage intervention (one hour of Swedish massage, once/week for eight weeks) at week 25. At week 34, 50% of patients will be randomized to a maintenance dose (one hour of Swedish massage every two weeks), while 50% will be randomized back to Usual Care.
  Intervention: Procedure: Massage Therapy

Inclusion Criteria:

• 35 years of age or greater.
• Written confirmation of OA of the knee as provided by the participant's physician.
• Radiographically-established OA of the knee.
• Pre-randomization rating within a certain range on the Visual Analog Pain Scale (0 - 100 mm scale).
• Receiving care for diagnosed OA of the knee under the care of a board-certified primary care physician, with or without involvement of a board-certified rheumatologist.
• Patients with bilateral knee involvement will have the more severely affected knee designated as the study knee.

• American College of Rheumatology defined OA of the knee; specifically:

  a. Knee pain b. Satisfaction of at least three of the following six criteria: i. Age great than 50 years ii. Stiffness < 30 minutes iii. Crepitus iv. Bony Tenderness v. Bony enlargement vi. No palpable warmth

Exclusion Criteria:

• Presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout.
• Presence of cancer or other decompensated medical conditions that limit the ability to participate fully in all interventions, assessments, and follow-up visits.
• Signs or history of kidney or liver failure.
• Presence of asthma requiring the use of corticosteroid treatment.
• Use of oral corticosteroids within the past four weeks.
• Use of intra-articular knee depo-corticosteroids with the past three months.
• Use of intra-articular hyaluronate with the past six months.
• Arthroscopic surgery of the knee within the past year.
• Significant injury to the knee within the past six months.
• Presence of a rash or open wound over the knee.
• Unable to satisfy the treatment and follow-up requirements.
• Unable to provide written informed consent.
• Currently receiving massage therapy on a regular basis (at least twice a month).
• Knee replacement of study knee (ok if the knee not being studied has been replaced).
• History of participating in the EMBARK Phase I or II studies.